510(k) Report

510(k) · Cleared

Cleared

Alertwatch: or

K130401510(k) TraditionalCleared Feb 7, 2014353-day reviewClass II21 CFR 870.1025

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

Alertwatch, LLC · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Feb 7, 2014 as substantially equivalent to K082583 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2009) after a 353-day review. Its family tree reaches back 27 generations to 1994. 8 later devices descend from it.

Decided
Feb 7, 2014
Review
353 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
1

Its longest line of descent runs back 27 generations to K941811 (1994). 172 ancestors in all, the oldest K844187 (1985). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 4 other ancestors2004: 12 other ancestors2003: 12 other ancestors2005: 2 other ancestors2002: 13 other ancestors2001: 7 other ancestors2000: 19 other ancestors1999: 10 other ancestors1998: 13 other ancestors1997: 7 other ancestors1996: 10 other ancestors1992: 6 other ancestors1989: 2 other ancestors1995: 6 other ancestors1994: 2 other ancestors1993: 5 other ancestors1991: 6 other ancestors1990: 6 other ancestors1987: 1 other ancestor1985: 1 other ancestor2015: 1 descendant cleared2016: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared2018: 1 descendant cleared2025: 1 descendant cleared2024: 2 descendants clearedK941811 · 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 · 2007K082583 · Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 6 other ancestors3 generations back: 29 other ancestors4 generations back: 54 other ancestors5 generations back: 18 other ancestors6 generations back: 17 other ancestors7 generations back: 12 other ancestors8 generations back: 8 other ancestors9 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants K082583 · Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 · 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. · 1994−25−20−15−10−50
  1. Root · 27 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 23 generations between
  3. 3 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  4. 2 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  5. 1 generation backK082583 Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  6. This deviceK130401 Alertwatch: orAlertwatch, LLC · 2014
  7. Descendant · cites it directly · 5 of its ownK142106 Decisio Health Patient DashboardDecisio Health, Inc. · 2015
  8. Descendant · 2 generations on · 3 of its ownK213335 Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022
  9. Descendant · cites it directly · 1 of its ownK153335 AlertWatch: ORAlertwatch, LLC · 2016
  10. Descendant · 3 generations on · 0 of its ownK241958 WARD-CSS (v1.2.x)Ward 24/7 Aps · 2025
  11. Descendant · 3 generations on · 0 of its ownK240756 Aitrics-VCAitrics Co., Ltd. · 2024
Show all 27 generations
  1. Root · 27 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 26 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 25 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 24 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 23 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 22 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 21 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 20 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 19 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 18 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 17 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 16 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 15 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 14 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 13 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 12 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 11 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 10 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 9 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 8 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 7 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 6 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 5 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 4 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 3 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 2 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 1 generation backK082583 Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  28. This deviceK130401 Alertwatch: orAlertwatch, LLC · 2014

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12018: 12022: 12023: 12024: 22025: 1
2015high 2 (2024) · low 0 (2017)2026

Most influential descendants

Showing 5 of 8 · See all
  • K142106Decisio Health Patient DashboardDecisio Health, Inc. · 2015 · cites it directly5descendants
  • K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022 · 2 generations on3descendants
  • K153335AlertWatch: ORAlertwatch, LLC · 2016 · cites it directly1descendant
  • K241958WARD-CSS (v1.2.x)Ward 24/7 Aps · 2025 · 3 generations on0descendants
  • K240756Aitrics-VCAitrics Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−27K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−26K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−25K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−24K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−23K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−22K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−21K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−20K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−19K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−18K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−17K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−16K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−15K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−14K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−13K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−12K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−11K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−10K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−9K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−8K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−7K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−6K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−5K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−4K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−3K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−2K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−1K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20095
0 (this device)K130401Alertwatch: orAlertwatch, LLC2014—
+1K142106Decisio Health Patient DashboardDecisio Health, Inc.2015—
+2K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.2022—
+1K153335AlertWatch: ORAlertwatch, LLC2016—
+3K241958WARD-CSS (v1.2.x)Ward 24/7 Aps2025—
+3K240756Aitrics-VCAitrics Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198920
199060
199160
199260
199350
199420
199560
1996100
199770
1998130
1999100
2000190
200170
2002130
2003120
2004120
200520
200640
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201810
202210
202310
202420
202510
FIG. 1 — Lineage of K130401, 1994–2025Source: 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.

Planning a device in MHX? 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 MHX device

  1. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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? (1)

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
*K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…
Summary page 5
…Email: [email protected] Date Prepared: January 30, 2014 Classification 21 CFR 870.1025 Regulation: Panel: . Cardiovascular Product Code: . MHX Predicate Device: K082583, Phillips MP90 Indication for Use: AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within o…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20095

Also cleared against K082583: 4 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142106Decisio Health Patient DashboardDecisio Health, Inc.20155
K153335AlertWatch: ORAlertwatch, LLC20161

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 9 companies; a new generation was cleared every 3 months on median.
  • 21 of the 172 ancestors have a recall of any class.
  • Of its descendants, K142106 (Decisio Health, Inc., 2015) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K082583.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MHX

8in 2025

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
2007high 21 (2026) · low 0 (2020)2026

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

Adverse event reports per year · MHX

3,761in 2025

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

What is it indicated for?

AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management systems and patient medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K082583

4 other devices cite the same predicate.

  • K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20135 recalls
  • K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013
  • K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012
  • K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20111 recall

More from Alertwatch, LLC

2 FDA decisions under this applicant name. See the company

  • K153335AlertWatch: ORAlertwatch, LLC · 2016

Recent decisions in MHX

The MHX category page

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K130401 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130401: Alertwatch: or.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130401

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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