510(k) Report

510(k) · Cleared

Cleared

Exspiron

K120087510(k) TraditionalCleared Sep 26, 2012259-day reviewClass II21 CFR 868.1850

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

Respiratory Motion, Inc. · BZK Spirometer, Monitoring (W/Wo Alarm)

Cleared on Sep 26, 2012 as substantially equivalent to K091853 (Nspire Health, Inc., 2009) and 1 other predicate after a 259-day review. Its family tree reaches back 22 generations to 1994. 8 later devices descend from it.

Decided
Sep 26, 2012
Review
259 days
Class
Class II
Product code
BZK
Recalls
None
Predicates
2

Its longest line of descent runs back 22 generations to K941811 (1994). 148 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 2009: 1 other ancestor2006: 2 other ancestors2004: 10 other ancestors2002: 10 other ancestors2005: 1 other ancestor2003: 8 other ancestors2000: 19 other ancestors1999: 9 other ancestors1998: 13 other ancestors1997: 7 other ancestors1996: 8 other ancestors1992: 6 other ancestors1991: 6 other ancestors2001: 5 other ancestors1995: 5 other ancestors1994: 2 other ancestors1993: 5 other ancestors1990: 5 other ancestors1989: 2 other ancestors1987: 1 other ancestor1985: 1 other ancestor2013: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant cleared2025: 1 descendant cleared2019: 1 descendant cleared2026: 1 descendant 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) ×8: 8 generations cleared close together, K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 27 other ancestors4 generations back: 48 other ancestors5 generations back: 22 other ancestors6 generations back: 11 other ancestors7 generations back: 11 other ancestors8 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants K060541 · 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. · 1994−20−15−10−50
  1. Root · 22 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 18 generations between
  3. 3 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  4. 2 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  5. 1 generation backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  6. This deviceK120087 ExspironRespiratory Motion, Inc. · 2012
  7. Descendant · cites it directly · 4 of its ownK130170 Exspiron 1XIRespiratory Motion, Inc. · 2013
  8. Descendant · 2 generations on · 3 of its ownK162131 ExSpiron 1XiRespiratory Motion, Inc. · 2017
  9. Descendant · cites it directly · 2 of its ownK190734 Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC · 2020
  10. Descendant · 3 generations on · 2 of its ownK173181 ExSpiron 1XiRespiratory Motion, Inc. · 2018
  11. Descendant · 2 generations on · 1 of its ownK240271 Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc. · 2024
Show all 22 generations
  1. Root · 22 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 21 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 20 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 19 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 18 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 17 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 16 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 15 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 14 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 13 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 12 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 11 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 10 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 9 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 8 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 7 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 6 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 5 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 4 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 3 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 2 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 1 generation backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. This deviceK120087 ExspironRespiratory Motion, Inc. · 2012

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2013: 12017: 12018: 12019: 12020: 12024: 12025: 12026: 1
2013high 1 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 8 · See all
  • K130170Exspiron 1XIRespiratory Motion, Inc. · 2013 · cites it directly4descendants
  • K162131ExSpiron 1XiRespiratory Motion, Inc. · 2017 · 2 generations on3descendants
  • K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC · 2020 · cites it directly2descendants
  • K173181ExSpiron 1XiRespiratory Motion, Inc. · 2018 · 3 generations on2descendants
  • K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−22K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−21K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−20K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−19K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−18K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−17K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−16K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−15K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−14K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−13K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−12K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−11K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−10K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−9K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−8K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−7K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−6K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−5K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−4K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−3K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−2K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−1K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
0 (this device)K120087ExspironRespiratory Motion, Inc.2012—
+1K130170Exspiron 1XIRespiratory Motion, Inc.2013—
+2K162131ExSpiron 1XiRespiratory Motion, Inc.2017—
+1K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC2020—
+3K173181ExSpiron 1XiRespiratory Motion, Inc.2018—
+2K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198920
199050
199160
199260
199350
199420
199550
199680
199770
1998130
199990
2000190
200150
2002100
200380
2004100
200510
200620
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201710
201810
201910
202010
202410
202510
202610
FIG. 1 — Lineage of K120087, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 BZK? 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 BZK device

  1. #1 K260226 ElintMAX Respiratory Monitor (ElintMAX Monitor…score 19.5 · 26 generations · no Class I recall
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
*K091853Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014
Summary page 1
…868.2375 Predicate devices: For product code BZK, nSpire Wright/Haloscale Respirometer, marketed by nSpire Health, Inc. of Longmont, CO 5 10(k) K09 1853 For product code BZQ, Philips MPnO Intellivue Patient Monitors, marketed by Philips…
Nspire Health, Inc.2009—
*K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors
Summary page 1
…, CO 5 10(k) K09 1853 For product code BZQ, Philips MPnO Intellivue Patient Monitors, marketed by Philips Healthcare 5 10(k) K060541I Device Description: The ExSpironTM consists of: * Bioimpedance measurement system: A stabilized high…
Philips Medizin Systeme Boblingen GmbH20062

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K130170Exspiron 1XIRespiratory Motion, Inc.20134
K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202

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 18 years and passes through 7 companies; a new generation was cleared every 4 months on median.
  • 15 of the 148 ancestors have a recall of any class.
  • Of its descendants, K130170 (Respiratory Motion, Inc., 2013) has gone furthest, with 4 descendants of its own.

How does its category compare?

All BZK devices

BZK Spirometer, Monitoring (W/Wo Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · BZK

2in 2019

2008: 12009: 32011: 12012: 12013: 12017: 12018: 22019: 22026 (partial year): 1
2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZK

71in 2009

2009: 71 days median
2007high 71 (2009)2026

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

Recalls per year · BZK

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · BZK

2in 2020

2009: 12012: 12013: 732014: 312015: 122016: 12017: 12018: 12020: 2
2007high 73 (2013) · low 0 (2007)2025

MAUDE reports naming product code BZK, 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
20070—00
20081—00
200937101
20100—00
20111—20
20121—01
20131—073
20140—031
20150—012
20160—01
20171—01
20182—01
20192—00
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20261—0—

What is it indicated for?

ExSpiron is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years of age) patients.

ExSpiron is a non-invasive system that graphically displays lung volume against time and reports an approximate value of:

* Tidal volume,

* Respiratory rate, and

* Minute ventilation.

ExSpiron measurements are used as an adjunct to other clinical information sources.

Indications for use as stated in the FDA summary.

More from Respiratory Motion, Inc.

4 FDA decisions under this applicant name. See the company

  • K173181ExSpiron 1XiRespiratory Motion, Inc. · 2018
  • K162131ExSpiron 1XiRespiratory Motion, Inc. · 2017
  • K130170Exspiron 1XIRespiratory Motion, Inc. · 2013

Recent decisions in BZK

The BZK category page

  • K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc. · 2026
  • K192584BEACON Caresystem Model 00002144Mermaid Care A/S · 2019
  • K192595ExSpiron 2XiRespiratory Motion · 2019
  • K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
  • K173181ExSpiron 1XiRespiratory Motion, Inc. · 2018

https://510kreport.com/device/K120087 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120087: Exspiron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120087

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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