510(k) Report

510(k) · Cleared

Cleared

Ventrak RMMS 1550

K960831510(k) TraditionalCleared May 29, 199690-day reviewClass II21 CFR 868.1880

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

Novametrix Medical Systems, Inc. · BZC Calculator, Pulmonary Function Data

Cleared on May 29, 1996 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 234 later devices descend from it.

Decided
May 29, 1996
Review
90 days
Class
Class II
Product code
BZC
Recalls
None
Predicates
0

234 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 9 descendants cleared2007: 3 descendants cleared2012: 9 descendants cleared2009: 5 descendants cleared2011: 8 descendants cleared2010: 6 descendants cleared2013: 12 descendants cleared2008: 5 descendants cleared2015: 7 descendants cleared2018: 14 descendants cleared2014: 10 descendants cleared2016: 11 descendants cleared2017: 12 descendants cleared2021: 13 descendants cleared2019: 10 descendants cleared2025: 21 descendants cleared2023: 21 descendants cleared2022: 18 descendants cleared2020: 9 descendants cleared2026: 13 descendants cleared2024: 18 descendants cleared1995200020052010201520202025
  1. This deviceK960831 Ventrak RMMS 1550Novametrix Medical Systems, Inc. · 1996
  2. Descendant · cites it directly · 233 of its ownK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  3. Descendant · 2 generations on · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  4. Descendant · 2 generations on · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  5. Descendant · 2 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  6. Descendant · 2 generations on · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006

Showing 5 of 234 descendants. See all descendants

Descendants cleared per year

2006: 92007: 32008: 52009: 52010: 62011: 82012: 92013: 122014: 102015: 72016: 112017: 122018: 142019: 102020: 92021: 132022: 182023: 212024: 182025: 212026: 13
2006high 21 (2023) · low 3 (2007)2026

Most influential descendants

Showing 5 of 234 · See all
  • K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH · 2006 · cites it directly233descendants
  • K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on222descendants
  • K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 2 generations on221descendants
  • K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 2 generations on211descendants
  • K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · 2 generations on188descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960831Ventrak RMMS 1550Novametrix Medical Systems, Inc.1996—
+1K053522Philips 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—
+2K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
+2K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
+2K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient…Philips Medical Systems North America, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200690
200730
200850
200950
201060
201180
201290
2013120
2014100
201570
2016110
2017120
2018140
2019100
202090
2021130
2022180
2023210
2024180
2025210
2026130
FIG. 1 — Lineage of K960831, 1996–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BZC? 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 BZC device

  1. #1 K240293 STSscore 9.8 · 7 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (234)

See all 234

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

NumberDeviceApplicantDecidedDescendants
K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233

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?

  • Of its descendants, K053522 (Philips Medizin Systeme Boeblingen GmbH, 2006) has gone furthest, with 233 descendants of its own.

How does its category compare?

All BZC devices

BZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZC

1in 2024

2007: 12011: 12014: 22015: 12016: 12017: 12018: 12019: 22024: 1
2007high 2 (2014) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZC

Too few BZC 510(k)s in any year since 2007 to give a median.

Recalls per year · BZC

3in 2009

2009: 3
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · BZC

3in 2025

2007: 12008: 32016: 42017: 12018: 12019: 72020: 32021: 52022: 92023: 82024: 82025: 3
2007high 9 (2022) · low 0 (2009)2025

MAUDE reports naming product code BZC, 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
20071—01
20080—03
20090—30
20100—00
20111—00
20120—00
20130—00
20142—00
20151—00
20161—04
20171—01
20181—01
20192—07
20200—03
20210—05
20220—09
20230—08
20241—08
20250—03
20260—0—

More from Novametrix Medical Systems, Inc.

58 FDA decisions under this applicant name. See the company

  • K010451Novametrix Marquette Compatible SensorsNovametrix Medical Systems, Inc. · 2001
  • K000794Modification to MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 20005 recalls
  • K993979MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 20001 recall
  • K982499Cosmo Plus with Nico, Model 8200Novametrix Medical Systems, Inc. · 19981 recall
  • K964360Vent (Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101Novametrix Medical Systems, Inc. · 1997

Recent decisions in BZC

The BZC category page

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https://510kreport.com/device/K960831 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960831: Ventrak RMMS 1550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960831

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026