510(k) · Cleared
ClearedMercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercury Medical · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Nov 4, 2002 as substantially equivalent to K894053 (Fenem, Inc., 1989) after a 174-day review. Its family tree reaches back 1 generation to 1989. 4 later devices descend from it.
- Decided
- Nov 4, 2002
- Review
- 174 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894053 (1989). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK894053 2ND Modification of Fef (TM) End-Tidal CO2 DetectorFenem, Inc. · 1989
- This deviceK021576 Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370Mercury Medical · 2002
- Descendant · cites it directly · 1 of its ownK133540 FlocapMaxtec, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK261633 VisuBreathAffirm Medical Technologies II, LLC · 2026
- Descendant · cites it directly · 0 of its ownK112840 Capnodura Combi & Capnodura Pedi CO2 DetectorSeebreath AB · 2012
- Descendant · cites it directly · 0 of its ownK031814 STATCO2METER, Model 10-55372Mercury Medical · 2003
Most influential descendants
Showing 4 of 4 · See all- K133540FlocapMaxtec, Inc. · 2014 · cites it directly1descendant
- K261633VisuBreathAffirm Medical Technologies II, LLC · 2026 · 2 generations on0descendants
- K112840Capnodura Combi & Capnodura Pedi CO2 DetectorSeebreath AB · 2012 · cites it directly0descendants
- K031814STATCO2METER, Model 10-55372Mercury Medical · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 Detector | Fenem, Inc. | 1989 | — |
| 0 (this device) | K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370 | Mercury Medical | 2002 | — |
| +1 | K133540 | Flocap | Maxtec, Inc. | 2014 | — |
| +2 | K261633 | VisuBreath | Affirm Medical Technologies II, LLC | 2026 | — |
| +1 | K112840 | Capnodura Combi & Capnodura Pedi CO2 Detector | Seebreath AB | 2012 | — |
| +1 | K031814 | STATCO2METER, Model 10-55372 | Mercury Medical | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2026 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 DetectorSummary page 1…tion: Class 11, 73CCK, 21 CFR 868.1400 Classification Name: ET Tube Placement Detector Device: STATCOzTMEnd Tidal C02 Detector Predicate Devices: Nellcor, Easy Cap 11,K894053 (FENEM submitter) Device Description: The Mercury Medical STATCOtTMuses the same technology as the Nellcor Easy Cap 11, (K89405… | 1989 |
| † | K000520 | C-IT | 2000 |
What descends from it? (4)
3 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?
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 Mercury Medical STATC02m' End Tidal C02 Detector is to
provide a semi-quantitative visualization of the C02 in the patient
airway. It is an adjunct in patient assessment, to be used in
conjunction with other methods to determine clinical signs and
symptoms by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021576: Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021576
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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