510(k) · Cleared
ClearedPhilips NM3 Respiratory Monitor with Ventassist
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 Jun 2, 2011 as substantially equivalent to K091459 (Respironics Novametrix, LLC, 2009) and 3 other predicates after a 178-day review. Its family tree reaches back 8 generations to 1991. 4 of the 45 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Jun 2, 2011
- Review
- 178 days
- Class
- Class II
- Product code
- BZK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K902859 (1991). 40 ancestors in all, the oldest K900696 (1990). 4 later devices descend from it, 2 citing it directly. 4 of the 45 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations backK961687 EVITA 4Drager, Inc. · 1996
- 6 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 5 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 4 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 3 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 2 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 1 generation backK053388 Model 840 Ventilator with Proportional Assist Ventilation Plus…Puritan Bennett Corp. · 2006 · Recalled (Class I)
- This deviceK103578 Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
- Descendant · cites it directly · 2 of its ownK222897 Enlight 2100Timpel S.A. · 2023
- Descendant · 2 generations on · 0 of its ownK250464 Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025
- Descendant · 2 generations on · 0 of its ownK243765 LuMon (TM) SystemSentec AG · 2025
- Descendant · cites it directly · 0 of its ownK192584 BEACON Caresystem Model 00002144Mermaid Care A/S · 2019
Class I recalls in this family
- K053388 Model 840 Ventilator with Proportional Assist…direct predicate · 2006
- K001646 Puritan-Bennett 840 Ventilator System with…3 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…3 generations back · 1998
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…4 generations back · 1998
Most influential descendants
Showing 4 of 4 · See all- K222897Enlight 2100Timpel S.A. · 2023 · cites it directly2descendants
- K250464Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025 · 2 generations on0descendants
- K243765LuMon (TM) SystemSentec AG · 2025 · 2 generations on0descendants
- K192584BEACON Caresystem Model 00002144Mermaid Care A/S · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −7 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −6 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −5 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −4 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −3 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −2 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −1 | K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option | Puritan Bennett Corp. | 2006 | Class I |
| 0 (this device) | K103578 | Philips NM3 Respiratory Monitor with Ventassist | Respironics Novametrix, LLC | 2011 | — |
| +1 | K222897 | Enlight 2100 | Timpel S.A. | 2023 | — |
| +2 | K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 2025 | — |
| +2 | K243765 | LuMon (TM) System | Sentec AG | 2025 | — |
| +1 | K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
4 devices in this family have 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 BZK device
- #1 K260226 ElintMAX Respiratory Monitor (ElintMAX Monitor…score 19.5 · 26 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K091459 | Philips NM3 Monitor, Model 7900Summary page 1…and promotional literature for predicate devices. The predicate devices are as follows: 1. Philips NM3 Respiratory Profile Monitor K091459 2. Bicore CP-100 Cardiopulmonary Monitor K900696 3. Puritan Bennett Model 840 Ventilator… | 2009 |
| * | K900696 | Biore CP-100 Cardiopulmonary MonitorSummary page 1…s are as follows: 1. Philips NM3 Respiratory Profile Monitor K091459 2. Bicore CP-100 Cardiopulmonary Monitor K900696 3. Puritan Bennett Model 840 Ventilator with PAV+ K053388 4. Dr~ger EvitaXL with Option SmartCare… | 1990 |
| * | K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionSummary page 1…K091459 2. Bicore CP-100 Cardiopulmonary Monitor K900696 3. Puritan Bennett Model 840 Ventilator with PAV+ K053388 4. Dr~ger EvitaXL with Option SmartCare K051263 e. Device Description The NMS monitor with… | 2006 |
| * | K051263 | Evitaxl with Option SmartcareSummary page 1…K900696 3. Puritan Bennett Model 840 Ventilator with PAV+ K053388 4. Dr~ger EvitaXL with Option SmartCare K051263 e. Device Description The NMS monitor with VentAssist is intended for non-invasive monitoring of the inspired and expi… | 2005 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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.
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 17 of the 40 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K222897 (Timpel S.A., 2023) has gone furthest, with 2 descendants of its own.
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. 2011, 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 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…
Read the full statement (217 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103578 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103578: Philips NM3 Respiratory Monitor with Ventassist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103578
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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