# K103578: Philips NM3 Respiratory Monitor with Ventassist

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Novametrix, LLC
- Decided: Jun 2, 2011 after 178 days
- Product code: BZK (Spirometer, Monitoring (W/Wo Alarm))
- Device class: 2
- Regulation: 21 CFR 868.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K902859 (1991). 40 ancestors in all.
4 later devices descend from it; 2 cite it directly.
4 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091459: Philips NM3 Monitor, Model 7900, Respironics Novametrix, LLC (2009) Summary page 1.
- K900696: Biore CP-100 Cardiopulmonary Monitor, Bicore Monitoring Systems (1990) Summary page 1.
- K053388: Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option, Puritan Bennett Corp. (2006) Summary page 1.
- K051263: Evitaxl with Option Smartcare, Drager Medical AG & Co. Kgaa (2005) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The intended use of the Philips INMV3 Respiratory Profile 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 CO2Iflow 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 welt or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). The intended use of the VentAssist software option isto provide: * non-invasive monitoring of work of breathing per minute in adult patients receiving pressure support mechanical ventilation. * on-demand advice in mechanically ventilated adult patients as prescribed by the caregiver regarding (a) modifications to the current pressure support settings in order to assess the work of breathing and breathing pattern and (b)modifications to ventilation in order to maintain end-tidal C02 in a range determined by the physician. The patients should be hemodynamically stable and must be breathing spontaneously.

Source page: https://510kreport.com/device/K103578
Methodology: https://510kreport.com/methodology