510(k) Report

510(k) · Cleared

Cleared

Spire Health Remote Patient Monitoring System

K192952510(k) TraditionalCleared Jun 5, 2020228-day reviewClass II21 CFR 870.2300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spire, Inc. D/B/A Spire Health · MSX System, Network And Communication, Physiological Monitors

Cleared on Jun 5, 2020 as substantially equivalent to K190073 (Current Health, Ltd., 2019) and 1 other predicate after a 228-day review. Its family tree reaches back 37 generations to 1994. 2 of the 332 devices in its family, counting itself, have a Class I recall.

Decided
Jun 5, 2020
Review
228 days
Class
Class II
Product code
MSX
Recalls
None
Predicates
2

Its longest line of descent runs back 37 generations to K941811 (1994). 331 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet. 2 of the 332 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2008: 6 other ancestors2014: 2 other ancestors2012: 4 other ancestors2004: 27 other ancestors2015: 1 other ancestor2011: 2 other ancestors2010: 9 other ancestors2006: 17 other ancestors1999: 18 other ancestors2013: 1 other ancestor2007: 8 other ancestors2005: 17 other ancestors2003: 16 other ancestors, 1 with a Class I recall12001: 14 other ancestors2000: 25 other ancestors1986: 2 other ancestors2009: 7 other ancestors1998: 19 other ancestors1996: 10 other ancestors1995: 11 other ancestors1994: 3 other ancestors1992: 8 other ancestors2002: 20 other ancestors1993: 7 other ancestors1991: 10 other ancestors1989: 6 other ancestors1985: 2 other ancestors1997: 12 other ancestors, 1 with a Class I recall11990: 8 other ancestors1982: 1 other ancestor1987: 1 other ancestorReference device: K181077 · ActiGraph CentrePoint Insight Watch · Actigraph · 2018K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) ×9: 9 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003), K040304 (2004), K041235 (2004) ×11: 11 generations cleared close together, K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006), K061052 (2006), K061610 (2006), K063315 (2006) K071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009×2: 2 generations cleared close together, K100939 (2010), K101449 (2010) K110622 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · recalledK111905 · Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011K122223 · New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO · Philips Medizin Systeme Boeblingen GmbH · 2013K151736 · Philips IntelliVue GuardianSoftware · Philips Medizin Systeme Boblingen GmbH · 2015K161767 · Philips IntelliVue GuardianSoftware · Philips Medizin Systeme Boeblingen GmbH · 2017×2: 2 generations cleared close together, K182543 (2018), K190073 (2019) 19801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 8 other ancestors4 generations back: 15 other ancestors5 generations back: 28 other ancestors6 generations back: 42 other ancestors7 generations back: 83 other ancestors, 1 with a Class I recall18 generations back: 62 other ancestors9 generations back: 24 other ancestors10 generations back: 14 other ancestors, 1 with a Class I recall111 generations back: 10 other ancestors12 generations back: 4 other ancestors K190073 · Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub · Current Health, Ltd. · 2019K182543 · Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package · Snap40, Ltd. · 2018K161767 · Philips IntelliVue GuardianSoftware · Philips Medizin Systeme Boeblingen GmbH · 2017K151736 · Philips IntelliVue GuardianSoftware · Philips Medizin Systeme Boblingen GmbH · 2015K122223 · New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO · Philips Medizin Systeme Boeblingen GmbH · 2013K111905 · Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011K110622 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · recalledK101449 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K100939 · Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K063315 · Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2006K061610 · Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K061052 · The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 · Philips Medical Systems North America, Inc. · 2006K060541 · The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors · Philips Medizin Systeme Boblingen GmbH · 2006 · recalledK060221 · The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K053522 · Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 · Philips Medizin Systeme Boeblingen GmbH · 2006K052801 · Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K051106 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K050762 · Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K050141 · The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K042845 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boblingen GmbH · 2004K041235 · Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2004K040304 · Philips Intellivue Patient Monitor, Models MP40 & MP50 · Philips Medizin Systeme Boeblingen GmbH · 2004K032858 · The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. · Philips Medizin Systeme Boblingen GmbH · 2003K031481 · The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 · Philips Medizin Systeme Boblingen GmbH · 2003K030038 · Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr · Philips Medical Systems, Inc. · 2003K023871 · M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology · Philips Medical Systems · 2002K021778 · Philips Component Compact Monitor, Release a.04, Model #M1275B · Philips Medical Systems · 2002K020531 · Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−35−30−25−20−15−10−50
  1. Root · 37 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 33 generations between
  3. 3 generations backK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
  4. 2 generations backK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
  5. 1 generation backK190073 Wearable Device, Home Package in Carry Case with Homehub, Home…Current Health, Ltd. · 2019
  6. This deviceK192952 Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health · 2020
Show all 37 generations
  1. Root · 37 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 36 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 35 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 34 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 33 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 32 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 31 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 30 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 29 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 28 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 27 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 26 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 25 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 24 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 23 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 22 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 21 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 20 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 19 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 18 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 17 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 16 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 15 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 14 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 13 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 12 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 11 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  28. 10 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  29. 9 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  30. 8 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  31. 7 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
  32. 6 generations backK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
  33. 5 generations backK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
  34. 4 generations backK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
  35. 3 generations backK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
  36. 2 generations backK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
  37. 1 generation backK190073 Wearable Device, Home Package in Carry Case with Homehub, Home…Current Health, Ltd. · 2019
  38. This deviceK192952 Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health · 2020

Class I recalls in this family

  • K031187 Heartstart MRX, Model M3535A7 generations back · 2003
  • K970209 Capnocheck Plus10 generations back · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−37K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−36K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−35K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−34K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−33K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−32K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−31K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−30K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−29K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−28K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−27K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−26K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−25K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−24K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−23K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−22K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−21K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−20K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−19K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−18K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−17K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−16K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−15K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−14K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−13K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−12K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−11K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
−10K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
−9K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−8K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−7K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20112
−6K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011—
−5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…Philips Medizin Systeme Boeblingen GmbH2013—
−4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH2015—
−3K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH2017—
−2K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple…Snap40, Ltd.2018—
−1K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in…Current Health, Ltd.2019—
0 (this device)K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198520
198620
198710
198960
199080
1991100
199280
199370
199430
1995110
1996100
1997121
1998190
1999180
2000250
2001140
2002200
2003161
2004270
2005170
2006170
200780
200860
200970
201090
201120
201240
201310
201420
201510
FIG. 1 — Lineage of K192952, 1994–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MSX device

  1. #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…
Summary page 4
…Product Code: MSX Subsequent Product Codes: DQA, FLL, BZQ, DRG 510(k) Number: K190073 Trade name: ActiGraph Gt9x-Link (originally cleared…
Current Health, Ltd.2019—
*K080545Actitrainer
Summary page 4
…Regulation Description: Measuring exercise equipment Product Code: ISD 510(k) Number: K080545 Section 5 – 510(k) Summary Page 1 of 9 Spire Health…
Actigraph, LLC2008—
†K181077ActiGraph CentrePoint Insight WatchActigraph2018—

Also cleared against K190073: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K031187Heartstart MRX, Model M3535APhilips Medical Systems · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls
  • K970209Capnocheck PlusBci Intl., Inc. · 1997 · 10 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 26 years and passes through 11 companies; a new generation was cleared every 4 months on median.
  • 54 of the 331 ancestors have a recall of any class; 2 have a Class I recall.
  • 1 other device also cites its predicate K190073.

How does its category compare?

All MSX devices

MSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · MSX

4in 2025

2007: 42008: 12009: 12010: 32011: 72012: 42013: 22014: 32015: 52016: 32017: 22018: 42019: 42020: 52021: 32022: 52023: 32024: 42025: 42026 (partial year): 5
2007high 7 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSX

295in 2025

2007: 58 days median2010: 43 days median2011: 72 days median2012: 145 days median2014: 165 days median2015: 138 days median2016: 174 days median2018: 111 days median2019: 92 days median2020: 193 days median2021: 227 days median2022: 177 days median2023: 244 days median2024: 212 days median2025: 295 days median2026 (partial year): 145 days median
2007high 295 (2025) · low 43 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MSX

1in 2025

2007: 12008: 12009: 22010: 12011: 12012: 22015: 22017: 22018: 12022: 12025: 12026 (partial year): 2
2007high 2 (2009) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MSX

19in 2025

2007: 52008: 62009: 72010: 142011: 32012: 42013: 172014: 322015: 312016: 112017: 162018: 152019: 152020: 252021: 172022: 182023: 102024: 322025: 19
2007high 32 (2014) · low 3 (2011)2025

MAUDE reports naming product code MSX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200745815
20081—16
20091—27
2010343114
201177213
2012414524
20132—017
20143165032
20155138231
20163174011
20172—216
20184111115
2019492015
20205193025
20213227017
20225177118
20233244010
20244212032
20254295119
202651452—

What is it indicated for?

The Spire Health Remote Patient Monitoring System is intended for reusable bedside and mobile multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Spire Health Remote Patient Monitoring System is intended for longitudinal monitoring of the following parameters in adults: - Pulse Rate - Respiratory Rate -…

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The Spire Health Remote Patient Monitoring System is intended for reusable bedside and mobile multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities or their own home. It is intended for monitoring of patients by trained healthcare professionals.

The Spire Health Remote Patient Monitoring System is intended for longitudinal monitoring of the following parameters in adults:

- Pulse Rate

- Respiratory Rate

- Sleep/Wake Behavior

- Activity associated with Movement

The Spire Health Remote Patient Monitoring System is intended only for general, non-diagnostic sleep and wake behavioral monitoring. It is not intended to assess sleep staging nor diagnose sleep disorders.

The Spire Health Remote Patient Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Spire Health Remote Patient Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG.

The Spire Health Remote Patient Monitoring System is not a substitute for an ECG monitor.

Indications for use as stated in the FDA summary.

Also cleared against K190073

1 other device cites the same predicate.

  • K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019

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https://510kreport.com/device/K192952 · printed Nov 5, 2026

Cite this page

510(k) Report. “K192952: Spire Health Remote Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192952

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026