510(k) · Cleared
ClearedVamos Anesthetic Gas Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Jan 17, 2002 as substantially equivalent to K913995 (Draeger Medical, Inc., 1992) and 1 other predicate after a 191-day review. Its family tree reaches back 1 generation to 1992. 2 of the 296 devices in its family, counting itself, have a Class I recall. 293 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 191 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913995 (1992). 2 ancestors in all. 293 later devices descend from it, 5 citing it directly. 2 of the 296 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK913995 Vitalert 3000 Monitoring SystemDraeger Medical, Inc. · 1992
- This deviceK012139 Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2002
- Descendant · cites it directly · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 270 of its ownK040847 Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004
- Descendant · cites it directly · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
- Descendant · 2 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 3 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
Showing 5 of 293 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 293 · See all- K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · cites it directly280descendants
- K040847Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004 · cites it directly270descendants
- K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · cites it directly251descendants
- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on249descendants
- K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on247descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913995 | Vitalert 3000 Monitoring System | Draeger Medical, Inc. | 1992 | — |
| 0 (this device) | K012139 | Vamos Anesthetic Gas Monitor | Draeger Medical, Inc. | 2002 | — |
| +1 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K040847 | Modification to Vamos Anesthetic Gas Monitor | Draeger Medical, Inc. | 2004 | — |
| +1 | K041956 | Emg - Essential Gas Module, Model M1013A | Draeget Medical AG & Co. Kgaa | 2004 | — |
| +2 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +3 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 7 | 0 |
| 2005 | 9 | 0 |
| 2006 | 14 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 11 | 0 |
| 2012 | 10 | 0 |
| 2013 | 13 | 0 |
| 2014 | 13 | 1 |
| 2015 | 12 | 0 |
| 2016 | 13 | 0 |
| 2017 | 13 | 0 |
| 2018 | 16 | 0 |
| 2019 | 11 | 0 |
| 2020 | 11 | 0 |
| 2021 | 15 | 0 |
| 2022 | 20 | 0 |
| 2023 | 22 | 1 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 17 | 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.
2 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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K913995 | Vitalert 3000 Monitoring SystemSummary page 1…Moislinger Allee Liibeck, Germany 23558 Establishment Registration No.: 9611500 Devices to which substantial equivalence is claimed: Vitalert 3000 Monitoring System — K913995 NPB4000 Pulse Oximeter — K962424 Device Description: The Vamos is an integrated monitoring system used for multiple gas analysi… | 1992 |
| * | K962424 | NPB-4000Summary page 1…y 23558 Establishment Registration No.: 9611500 Devices to which substantial equivalence is claimed: Vitalert 3000 Monitoring System — K913995 NPB4000 Pulse Oximeter — K962424 Device Description: The Vamos is an integrated monitoring system used for multiple gas analysis (CO, N0, and anesthetic agent c… | 1996 |
What descends from it? (293)
See all 2935 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio | 2003 | 280 |
| K040847 | Modification to Vamos Anesthetic Gas Monitor | 2004 | 270 |
| K041956 | Emg - Essential Gas Module, Model M1013A | 2004 | 251 |
| K053204 | Intellivue Gas Modules, Models G5 M1019A and G1 M1013A | 2006 | 222 |
| K061816 | Galaxy | 2006 | 0 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K031340 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 280 descendants of its own.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
The Vamos Variable Anesthetic Gas Monitor is indicated for measuring and monitoring the CO2 concentration, functional oxygen saturation Sp02, pulse rate and the concentrations of N20, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012139: Vamos Anesthetic Gas Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012139
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026