510(k) · Cleared
Recalled · 2011Mercury VCO2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Novametrix, Inc. · BZK Spirometer, Monitoring (W/Wo Alarm)
Cleared on Aug 21, 2009 as substantially equivalent to K080652 (Respironics Novametrix, LLC, 2008) after a 30-day review. Its family tree reaches back 7 generations to 1997. It has been recalled 4 times.
- Decided
- Aug 21, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- BZK
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962603 (1997). 11 ancestors in all, the oldest K913516 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK993979 MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 2000 · Recalled
- 2 generations backK030886 Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · Recalled
- 1 generation backK080652 Mercury VCO2 Module with Capnostat 5Respironics Novametrix, LLC · 2008 · Recalled
- This deviceK092217 Mercury VCO2Respironics Novametrix, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K993979 | MARSPO2, Model 2001 | Novametrix Medical Systems, Inc. | 2000 | 1 |
| −2 | K030886 | Nico with Mars, Model 7300 | Respironics Novametrix, Inc. | 2003 | 8 |
| −1 | K080652 | Mercury VCO2 Module with Capnostat 5 | Respironics Novametrix, LLC | 2008 | 4 |
| 0 (this device) | K092217 | Mercury VCO2 | Respironics Novametrix, Inc. | 2009 | — |
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 |
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 |
|---|---|---|---|
| * | K080652 | Mercury VCO2 Module with Capnostat 5Summary page 1…pirometer with CO2 sensor Classification Name: Class II,21 CFR 868.1850 and 868.1400 Predicate Device: Mercury Module with Capnostat 5 CO2 sensor (K080652) Description of Device: The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 6 of the 11 ancestors have a recall of any class.
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 Mercury module with Capnostat 5 is to provide: 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 CO2/flow sensors are provided for adult, pediatric and neonatal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092217 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092217: Mercury VCO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092217
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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