510(k) · Cleared
ClearedIntellivue Gas Modules, Models G5 M1019A and G1 M1013A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical AG & Co. Kgaa · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Feb 3, 2006 as substantially equivalent to K012139 (Draeger Medical, Inc., 2002) and 5 other predicates after a 79-day review. Its family tree reaches back 7 generations to 1995. 222 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 79 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K946306 (1995). 40 ancestors in all, the oldest K844187 (1985). 222 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 6 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 5 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 4 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 3 generations backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- 2 generations backK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- 1 generation backK051628 Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005
- This deviceK053204 Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006
- Descendant · cites it directly · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- Descendant · 2 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- Descendant · 2 generations on · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
- Descendant · 2 generations on · 176 of its ownK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · 3 generations on · 175 of its ownK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 222 · See all- K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · cites it directly221descendants
- K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 2 generations on211descendants
- K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · 2 generations on188descendants
- K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on176descendants
- K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 3 generations on175descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −6 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −5 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −4 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −2 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| −1 | K051628 | Infinity Monitors with Scio Modifications | Draeger Medical Systems, Inc. | 2005 | — |
| 0 (this device) | K053204 | Intellivue Gas Modules, Models G5 M1019A and G1 M1013A | Draeger Medical AG & Co. Kgaa | 2006 | — |
| +1 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| +2 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| +2 | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient… | Philips Medical Systems North America, Inc. | 2006 | — |
| +2 | K062392 | Philips MP5 Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +3 | K063725 | MP5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 13 | 0 |
| 2019 | 9 | 0 |
| 2020 | 9 | 0 |
| 2021 | 13 | 0 |
| 2022 | 18 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 13 | 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 CCK? 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? (6)
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 2…AD erarnd Sinen erns mpany Legally marketed device to which Substantial Equivalence is claimed VAMOS (K012139, K040847) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. SCIO (… | 2002 |
| * | K040847 | Modification to Vamos Anesthetic Gas MonitorSummary page 2…AD erarnd Sinen erns mpany Legally marketed device to which Substantial Equivalence is claimed VAMOS (K012139, K040847) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. SCIO (with Infi… | 2004 |
| * | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSummary page 2…K012139, K040847) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. SCIO (with Infinity Patient Monitors) (K031340, K051628) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. Philip… | 2003 |
| * | K051628 | Infinity Monitors with Scio ModificationsSummary page 2…K040847) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. SCIO (with Infinity Patient Monitors) (K031340, K051628) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. Philips M10263… | 2005 |
| * | K040917 | Philips Anesthesia Gas Monitor, Model M1026BSummary page 2…raeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. Philips M10263 Anesthetic Gas Monitor (with IntelliVue Patient Monitors) (K040917) Distributed in the United States by Philips Medical Systems EGM - Essential Gas Monitor (K041956) Manufactured by Draeger Medic… | 2004 |
| * | K041956 | Emg - Essential Gas Module, Model M1013ASummary page 2…lips M10263 Anesthetic Gas Monitor (with IntelliVue Patient Monitors) (K040917) Distributed in the United States by Philips Medical Systems EGM - Essential Gas Monitor (K041956) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. Description of… | 2004 |
What descends from it? (222)
See all 2221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors | 2006 | 221 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 40 ancestors have a recall of any class.
- Of its descendants, K060541 (Philips Medizin Systeme Boblingen GmbH, 2006) has gone furthest, with 221 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 IntelliVue gas modules are indicated for measuring and monitoring CO2 concentration and the concentrations of N 20, 02, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053204: Intellivue Gas Modules, Models G5 M1019A and G1 M1013A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053204
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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