510(k) · Cleared
Recalled · 2011Philips NM3 Monitor, Model 7900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Novametrix, LLC · BZK Spirometer, Monitoring (W/Wo Alarm)
Cleared on Jul 28, 2009 as substantially equivalent to K030886 (Respironics Novametrix, Inc., 2003) after a 71-day review. Its family tree reaches back 6 generations to 1997. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 28, 2009
- Review
- 71 days
- Class
- Class II
- Product code
- BZK
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962603 (1997). 10 ancestors in all, the oldest K913516 (1991). 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK993979 MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 2000 · Recalled
- 1 generation backK030886 Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · Recalled
- This deviceK091459 Philips NM3 Monitor, Model 7900Respironics Novametrix, LLC · 2009
- Descendant · cites it directly · 4 of its ownK103578 Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK222897 Enlight 2100Timpel S.A. · 2023
- Descendant · 3 generations on · 0 of its ownK250464 Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025
- Descendant · 3 generations on · 0 of its ownK243765 LuMon (TM) SystemSentec AG · 2025
- Descendant · 2 generations on · 0 of its ownK192584 BEACON Caresystem Model 00002144Mermaid Care A/S · 2019
Most influential descendants
Showing 5 of 5 · See all- K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011 · cites it directly4descendants
- K222897Enlight 2100Timpel S.A. · 2023 · 2 generations on2descendants
- K250464Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025 · 3 generations on0descendants
- K243765LuMon (TM) SystemSentec AG · 2025 · 3 generations on0descendants
- K192584BEACON Caresystem Model 00002144Mermaid Care A/S · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K993979 | MARSPO2, Model 2001 | Novametrix Medical Systems, Inc. | 2000 | 1 |
| −1 | K030886 | Nico with Mars, Model 7300 | Respironics Novametrix, Inc. | 2003 | 8 |
| 0 (this device) | K091459 | Philips NM3 Monitor, Model 7900 | Respironics Novametrix, LLC | 2009 | — |
| +1 | K103578 | Philips NM3 Respiratory Monitor with Ventassist | Respironics Novametrix, LLC | 2011 | — |
| +2 | K222897 | Enlight 2100 | Timpel S.A. | 2023 | — |
| +3 | K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 2025 | — |
| +3 | K243765 | LuMon (TM) System | Sentec AG | 2025 | — |
| +2 | K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
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 K260226 ElintMAX Respiratory Monitor (ElintMAX Monitor…score 19.5 · 26 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030886 | Nico with Mars, Model 7300Summary page 1…alve). Classification Name: Class II,21 CFR 868.1850, 868.1400, 868.5675 and 870.2700 Predicate Device: NICO with MARS monitor, Model 7300 [510(k) K030886] Description of Device: The Philips NM3 monitor is intended for non-invasive monitoring of the inspired and expired airflow and… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103578 | Philips NM3 Respiratory Monitor with Ventassist | 2011 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2011 | Not classified | Z-3288-2011 | Manufacturing material removal | Pressure lines maybe occluded and display incorrect tidal volumes. |
| Jul 29, 2011 | Not classified | Z-3287-2011 | Manufacturing material removal | Pressure lines maybe occluded and display incorrect tidal volumes. |
| Jan 4, 2011 | Not classified | Z-2168-2011 | Software design | Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than… |
| Jan 4, 2011 | Not classified | Z-2167-2011 | Software design | Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K103578 (Respironics Novametrix, LLC, 2011) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K030886.
How does its category compare?
All BZK devicesBZK Spirometer, Monitoring (W/Wo Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BZK
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · BZK
71in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZK
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZK
2in 2020
MAUDE reports naming product code BZK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 71 | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of the Philips NM3 monitor, Model 7900 is to provide: cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU). spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination…
Read the full statement (191 words)
The intended use of the Philips NM3 monitor, Model 7900 is to provide:
cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination C02/flow sensors are provided for adult, pediatric and neonatal use.
continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).
The NM3 monitor Model 7900 and its sensors are intended to be used by trained operators when spirometric, capnographic, pulse oximetry, or cardiac output monitoring is indicated in the judgement of a physician.
The use of the NM3 monitor Model 7900 for cardiac output monitoring is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of C02 level cannot be tolerated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091459 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091459: Philips NM3 Monitor, Model 7900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091459
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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