510(k) · Cleared
ClearedInfinity Mcable - Mainstream CO2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical AG & Co. KG · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Apr 23, 2010 as substantially equivalent to K051263 (Drager Medical AG & Co. Kgaa, 2005) and 1 other predicate after an 18-day review. Its family tree reaches back 7 generations to 1991. 3 of the 34 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Apr 23, 2010
- Review
- 18 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K902859 (1991). 32 ancestors in all, the oldest K902506 (1991). 1 later device descends from it, 1 citing it directly. 3 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK961687 EVITA 4Drager, Inc. · 1996
- 5 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 4 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 3 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 2 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 1 generation backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- This deviceK100941 Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG · 2010
- Descendant · cites it directly · 0 of its ownK221118 CO2 Mainstream SensorDraegerwerk AG & CO Kgaa · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −5 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −4 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −3 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −2 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −1 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| 0 (this device) | K100941 | Infinity Mcable - Mainstream CO2 | Draeger Medical AG & Co. KG | 2010 | — |
| +1 | K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
3 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 |
|---|---|---|---|
| * | K051263 | Evitaxl with Option SmartcareSummary page 2…~ger and Siemens Company Legally Marketed Predicate Device to which Substantial Equivalence is claimed: 510(k) number Trade name Company K 051263 Evita XL, Option Dr~ger Medical AG & Co. KG - SmartCare with… | 2005 |
| * | K042601 | Capnostat 5Summary page 2…Option Capno Package 002 Mainstream sensor #6871500 K 042601 CAPNOSTAT 5 RESPIRONICS NOVAMETRIX, INC. Device Description: The Infinity Moable - Mainstre… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221118 | CO2 Mainstream Sensor | 2023 | 0 |
Has anything in its family been recalled? (3 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.
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 14 of the 32 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K221118 (Draegerwerk AG & CO Kgaa, 2023) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K051263.
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. 2010, this device’s year, is highlighted.
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 Droger Dr~ger Infinty MCable Mainstream C02 sensor is meant to be used for continuous, real time measurement of C02 concentrations of ventilated patients from neonates to adults.
This sensor is only intended for use with devices made by Dr~ger Medical, or with devices which are approved for use with Drager C02 components (Drtiger-compatible devices).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100941 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100941: Infinity Mcable - Mainstream CO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100941
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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