510(k) · Cleared
ClearedEmg - Essential Gas Module, Model M1013A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeget Medical AG & Co. Kgaa · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Aug 9, 2004 as substantially equivalent to K012139 (Draeger Medical, Inc., 2002) and 3 other predicates after a 19-day review. Its family tree reaches back 5 generations to 1995. 251 later devices descend from it.
- Decided
- Aug 9, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K946306 (1995). 28 ancestors in all, the oldest K900598 (1990). 251 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 4 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 3 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 1 generation backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- This deviceK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
- Descendant · cites it directly · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 2 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 2 generations on · 234 of its ownK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 2 generations on · 233 of its ownK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · 2 generations on · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
Showing 5 of 251 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 251 · See all- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly249descendants
- K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on247descendants
- K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on234descendants
- K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on233descendants
- K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on222descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −4 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −3 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| 0 (this device) | K041956 | Emg - Essential Gas Module, Model M1013A | Draeget Medical AG & Co. Kgaa | 2004 | — |
| +1 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +2 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +2 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +2 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +2 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 5 | 0 |
| 2006 | 11 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 12 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 19 | 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? (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 |
|---|---|---|---|
| * | K012139 | Vamos Anesthetic Gas MonitorSummary page 2…ADr~gerandSiemensCompany OEM variant of VAMOS Legally marketed device to which Substantial Equivalence is claimed VAMOS (K012139, K040847) Manufactured by Dr~ger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. SCIO (w… | 2002 |
| * | K040847 | Modification to Vamos Anesthetic Gas MonitorSummary page 2…ADr~gerandSiemensCompany OEM variant of VAMOS Legally marketed device to which Substantial Equivalence is claimed VAMOS (K012139, K040847) Manufactured by Dr~ger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. SCIO (with Infin… | 2004 |
| * | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSummary page 2…(K012139, K040847) Manufactured by Dr~ger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. SCIO (with Infinity Patient Monitors) (K031340) Manufactured by Drtger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. Philips M1026B A… | 2003 |
| * | K040917 | Philips Anesthesia Gas Monitor, Model M1026BSummary page 2…Drtger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc. Philips M1026B Anesthetic Gas Monitor (with IntelliVue Patient Monitors) (K040917) Distributed in the United States by Philips Medical Systems Description of the Device The M1013A Essential Gas Module provide… | 2004 |
What descends from it? (251)
See all 2512 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K050762 (Philips Medizin Systeme Boeblingen GmbH, 2005) has gone furthest, with 249 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 EGM gas monitor is indicated for measuring and monitoring C02 concentration and the concentrations of N20, 02, Halothane, Enflurane, Isoflurane, Sevoflurane and Desfiurane.
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/K041956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041956: Emg - Essential Gas Module, Model M1013A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041956
Report an extraction error
Are you the manufacturer?
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