510(k) · Cleared
Cleared2ND Modification of Fef (TM) End-Tidal CO2 Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fenem, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Jul 20, 1989 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jul 20, 1989
- Review
- 43 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 5 citing it directly.
- This deviceK894053 2ND Modification of Fef (TM) End-Tidal CO2 DetectorFenem, Inc. · 1989
- Descendant · cites it directly · 6 of its ownK960468 DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc. · 1996
- Descendant · 2 generations on · 5 of its ownK973419 DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK021576 Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370Mercury Medical · 2002
- Descendant · 2 generations on · 1 of its ownK133540 FlocapMaxtec, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK042572 Kendall CO2NFIRM Now CO2 DetectorKendall · 2004
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K960468DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc. · 1996 · cites it directly6descendants
- K973419DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998 · 2 generations on5descendants
- K021576Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370Mercury Medical · 2002 · cites it directly4descendants
- K133540FlocapMaxtec, Inc. · 2014 · 2 generations on1descendant
- K042572Kendall CO2NFIRM Now CO2 DetectorKendall · 2004 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 Detector | Fenem, Inc. | 1989 | — |
| +1 | K960468 | DMR/CO2 Combo Kti | Nellcor Puritan Bennett, Inc. | 1996 | — |
| +2 | K973419 | DMR Plus Disposable Manual Resuscitator | Nellcor Puritan Bennett, Inc. | 1998 | — |
| +1 | K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370 | Mercury Medical | 2002 | — |
| +2 | K133540 | Flocap | Maxtec, Inc. | 2014 | — |
| +1 | K042572 | Kendall CO2NFIRM Now CO2 Detector | Kendall | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960468 | DMR/CO2 Combo Kti | 1996 | 6 |
| K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370 | 2002 | 4 |
| K042572 | Kendall CO2NFIRM Now CO2 Detector | 2004 | 1 |
| K991955 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2… | 1999 | 0 |
| K991953 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2… | 1999 | 0 |
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?
- Of its descendants, K960468 (Nellcor Puritan Bennett, Inc., 1996) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K894053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894053: 2ND Modification of Fef (TM) End-Tidal CO2 Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894053
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026