510(k) Report

510(k) · Cleared

Cleared

Linshom Respiratory Monitoring Device (LRMD)

K190734510(k) TraditionalCleared Jan 30, 2020315-day reviewClass II21 CFR 868.2375

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

Linshom Management, LLC · BZQ Monitor, Breathing Frequency

Cleared on Jan 30, 2020 as substantially equivalent to K120087 (Respiratory Motion, Inc., 2012) after a 315-day review. Its family tree reaches back 23 generations to 1994. 2 later devices descend from it.

Decided
Jan 30, 2020
Review
315 days
Class
Class II
Product code
BZQ
Recalls
None
Predicates
1

Its longest line of descent runs back 23 generations to K941811 (1994). 149 ancestors in all, the oldest K844187 (1985). 2 later devices descend from it, 1 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 ancestor2024: 1 descendant cleared2025: 1 descendant clearedReference device: K161953 · ReDe Mask · Tereopneuma · 2017K941811 · 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) K120087 · Exspiron · Respiratory Motion, Inc. · 20121990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 27 other ancestors5 generations back: 48 other ancestors6 generations back: 22 other ancestors7 generations back: 11 other ancestors8 generations back: 11 other ancestors9 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K120087 · Exspiron · Respiratory Motion, Inc. · 2012K060541 · 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 · 23 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 19 generations between
  3. 3 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  4. 2 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  5. 1 generation backK120087 ExspironRespiratory Motion, Inc. · 2012
  6. This deviceK190734 Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC · 2020
  7. Descendant · cites it directly · 1 of its ownK240271 Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc. · 2024
  8. Descendant · 2 generations on · 0 of its ownK250093 Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc. · 2025
Show all 23 generations
  1. Root · 23 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 22 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 21 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 20 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 19 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 18 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 17 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 16 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 15 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 14 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 13 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 12 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 11 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 10 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 9 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 8 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 7 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 6 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 5 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 4 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 3 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 2 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 1 generation backK120087 ExspironRespiratory Motion, Inc. · 2012
  24. This deviceK190734 Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc. · 2024 · cites it directly1descendant
  • K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−23K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−22K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−21K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−20K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−19K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−18K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−17K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−16K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−15K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−14K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−13K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−12K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−11K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−10K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−9K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−8K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−7K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−6K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−5K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−4K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−3K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−2K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−1K120087ExspironRespiratory Motion, Inc.2012—
0 (this device)K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC2020—
+1K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.2024—
+2K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.2025—

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
202410
202510
FIG. 1 — Lineage of K190734, 1994–2025Source: 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 BZQ? 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 BZQ device

  1. #1 K251326 Respiration Rate algorithmscore 20.2 · 30 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
*K120087Exspiron
Summary page 4
…on Breathing frequency monitor 21 CFR 878.2375 (Product Code BZQ) Predicate Device Information Primary Predicate ExSpiron, K120087 Reference Device ReDe Mask, K161953 Device Description The Linshom Respiratory Monitoring Device (LRMD) is a medica…
Respiratory Motion, Inc.2012—
†K161953ReDe MaskTereopneuma2017—

Also cleared against K120087: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241

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 26 years and passes through 8 companies; a new generation was cleared every 4 months on median.
  • 15 of the 149 ancestors have a recall of any class.
  • Of its descendants, K240271 (Linshom Medical, Inc., 2024) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K120087.

How does its category compare?

All BZQ devices

BZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · BZQ

7in 2025

2007: 22008: 12009: 32010: 22011: 12012: 22013: 32014: 22016: 22018: 32019: 12020: 22021: 22022: 32023: 12024: 12025: 72026 (partial year): 2
2007high 7 (2025) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZQ

255in 2025

2009: 121 days median2013: 261 days median2018: 198 days median2022: 198 days median2025: 255 days median
2007high 261 (2013) · low 121 (2009)2026

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

Recalls per year · BZQ

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · BZQ

2in 2022

2007: 72009: 12010: 12012: 32017: 112018: 102019: 132020: 102021: 12022: 2
2007high 13 (2019) · low 0 (2008)2025

MAUDE reports naming product code BZQ, 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
20072—07
20081—00
2009312101
20102—11
20111—00
20122—03
2013326100
20142—00
20150—00
20162—00
20170—011
20183198010
20191—013
20202—010
20212—01
2022319802
20231—00
20241—00
2025725500
20262—0—

What is it indicated for?

Linshom Respiratory Monitoring Device (LRMD) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult (at least 22 years of age) patients.

LRMD is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume.

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

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K190734: Linshom Respiratory Monitoring Device (LRMD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190734

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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