# K091459: Philips NM3 Monitor, Model 7900

- Pathway: 510(k) (Special)
- Applicant: Respironics Novametrix, LLC
- Decided: Jul 28, 2009 after 71 days
- Product code: BZK (Spirometer, Monitoring (W/Wo Alarm))
- Device class: 2
- Regulation: 21 CFR 868.1850
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 10 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030886: Nico with Mars, Model 7300, Respironics Novametrix, Inc. (2003) Summary page 1.

## Most influential descendants
- K103578: Philips NM3 Respiratory Monitor with Ventassist (2011), 4 descendants of its own
- K222897: Enlight 2100 (2023), 2 descendants of its own
- K250464: Enlight 2100 (TPL-E2103-0) (2025), 0 descendants of its own
- K243765: LuMon (TM) System (2025), 0 descendants of its own
- K192584: BEACON Caresystem Model 00002144 (2019), 0 descendants of its own

## Recalls of this device
- Jul 29, 2011 · Not classified · Z-3288-2011: Pressure lines maybe occluded and display incorrect tidal volumes.
- Jul 29, 2011 · Not classified · Z-3287-2011: Pressure lines maybe occluded and display incorrect tidal volumes.
- Jan 4, 2011 · Not classified · Z-2168-2011: 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 d
- Jan 4, 2011 · Not classified · Z-2167-2011: 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 d

## Indications for use
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.

Source page: https://510kreport.com/device/K091459
Methodology: https://510kreport.com/methodology