510(k) Report

510(k) · Cleared

Recalled · 2009

CO 2 Smo Plus

K963380510(k) TraditionalCleared Jan 22, 1997148-day reviewClass II21 CFR 868.1880Recalls 3

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 Jan 22, 1997 after a 148-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 240 devices in its family, counting itself, has a Class I recall. 239 later devices descend from it. It has been recalled 3 times.

Decided
Jan 22, 1997
Review
148 days
Class
Class II
Product code
BZC
Recalls
3
Predicates
0

239 later devices descend from it, 3 citing it directly. 1 of the 240 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2006: 9 descendants cleared2000: 1 descendant cleared2008: 6 descendants cleared, 1 with a Class I recall12007: 3 descendants cleared2012: 9 descendants cleared2009: 5 descendants cleared2011: 9 descendants cleared2010: 7 descendants cleared2013: 12 descendants cleared2015: 7 descendants cleared2018: 14 descendants cleared2014: 10 descendants cleared2016: 11 descendants cleared2017: 12 descendants cleared2021: 14 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 deviceK963380 CO 2 Smo PlusNovametrix Medical Systems, Inc. · 1997
  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 239 descendants. See all descendants

Descendants cleared per year

2000: 12006: 92007: 32008: 62009: 52010: 72011: 92012: 92013: 122014: 102015: 72016: 112017: 122018: 142019: 102020: 92021: 142022: 182023: 212024: 182025: 212026: 13
2000high 21 (2023) · low 0 (2001)2026

Class I recalls in this family

  • K073069 Modification to Avea Ventilatorcites it directly · 2008

Most influential descendants

Showing 5 of 239 · 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)K963380CO 2 Smo PlusNovametrix Medical Systems, Inc.1997—
+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
200010
200690
200730
200861
200950
201070
201190
201290
2013120
2014100
201570
2016110
2017120
2018140
2019100
202090
2021140
2022180
2023210
2024180
2025210
2026130
FIG. 1 — Lineage of K963380, 1997–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has 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 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? (239)

See all 239

3 later devices cite 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
K073069Modification to Avea Ventilator Class IViasys Respiratory Care, Inc.20083
K992116Siememns Infinity ETC02 PodSiemens Medical Solutions USA, Inc.20000

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 19, 2009Not classifiedZ-1291-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009Not classifiedZ-1275-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009Not classifiedZ-1274-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…

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.

  • K073069Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 113 Class I recalls

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

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The BZC category page

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https://510kreport.com/device/K963380 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963380: CO 2 Smo Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963380

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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