510(k) · Cleared
ClearedModification to Vamos 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 Jun 17, 2004 as substantially equivalent to K012139 (Draeger Medical, Inc., 2002) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1992. 2 of the 276 devices in its family, counting itself, have a Class I recall. 270 later devices descend from it.
- Decided
- Jun 17, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K913995 (1992). 5 ancestors in all. 270 later devices descend from it, 4 citing it directly. 2 of the 276 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK913995 Vitalert 3000 Monitoring SystemDraeger Medical, Inc. · 1992
- 1 generation backK012139 Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2002
- This deviceK040847 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
- Descendant · 3 generations on · 234 of its ownK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 3 generations on · 233 of its ownK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
Showing 5 of 270 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 270 · See all- 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
- K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on234descendants
- K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH · 2006 · 3 generations on233descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913995 | Vitalert 3000 Monitoring System | Draeger Medical, Inc. | 1992 | — |
| −1 | K012139 | Vamos Anesthetic Gas Monitor | Draeger Medical, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +3 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +3 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 10 | 0 |
| 2012 | 10 | 0 |
| 2013 | 12 | 0 |
| 2014 | 13 | 1 |
| 2015 | 10 | 0 |
| 2016 | 12 | 0 |
| 2017 | 12 | 0 |
| 2018 | 16 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 15 | 0 |
| 2022 | 20 | 0 |
| 2023 | 22 | 1 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 16 | 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? (3)
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 |
|---|---|---|---|
| * | K012139 | Vamos Anesthetic Gas MonitorSummary page 1…5 Moislinger Allee Luebeck, Germany Establishment Registration Number: 9611500 Devices to which substantial equivalence is claimed: Vamos Anesthetic Gas Monitor K012139 As/3 Anesthesia Delivery Unit (As/3Adu) K973985 Capnomac Ultima Anesthesia Monitor K932098 Device Description: Th… | 2002 |
| * | K973985 | AS/3 Anaesthesia Delivery Unit (as/3 Adu)Summary page 1…stration Number: 9611500 Devices to which substantial equivalence is claimed: Vamos Anesthetic Gas Monitor K012139 As/3 Anesthesia Delivery Unit (As/3Adu) K973985 Capnomac Ultima Anesthesia Monitor K932098 Device Description: The modified Vamos is an integrated monitoring system use… | 1998 |
| * | K932098 | Capnomac Ultima Anesthesia MonitorSummary page 1…tial equivalence is claimed: Vamos Anesthetic Gas Monitor K012139 As/3 Anesthesia Delivery Unit (As/3Adu) K973985 Capnomac Ultima Anesthesia Monitor K932098 Device Description: The modified Vamos is an integrated monitoring system used for the multiple gas analysis (CO2), N20), and a… | 1993 |
What descends from it? (270)
See all 2704 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 9.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K041956 (Draeget Medical AG & Co. Kgaa, 2004) has gone furthest, with 251 descendants of its own.
- 4 other devices also cite its predicate K012139.
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 Anesthetic Gas monitor is indicated for measuring and monitoring CO2 concentration, functional oxygen saturation (SPO2), pulse rate and the concentrations of N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040847 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040847: Modification to Vamos Anesthetic Gas Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040847
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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