510(k) · Cleared
ClearedSTATCO2METER, Model 10-55372
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 Aug 14, 2003 as substantially equivalent to K021576 (Mercury Medical, 2002) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Aug 14, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894053 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 Detector | Fenem, Inc. | 1989 | — |
| −1 | K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370 | Mercury Medical | 2002 | — |
| 0 (this device) | K031814 | STATCO2METER, Model 10-55372 | Mercury Medical | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (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 |
|---|---|---|---|
| * | K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370Summary page 1…1, CCK, 21 CFR 868.1400 Classification Name: Analyzer, Gas, Carbon Dioxide, Gaseous Phase Device: StatC02meterM Predicate Devices: StatCQzM(K021576)and Airway Pressure Manometer (K954486) Device DescriDtion: The Mercury Medical… | 2002 |
| * | K954486 | Mercury Airway Pressure ManometerSummary page 1…s, Carbon Dioxide, Gaseous Phase Device: StatC02meterM Predicate Devices: StatCQzM(K021576)and Airway Pressure Manometer (K954486) Device DescriDtion: The Mercury Medical StatC@meterTMis a fast, durable colorimetric breath indica… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 2 companies; a new generation was cleared every 13.3 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K021576.
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 StatC02meterTM End Tidal C02 Detector with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the C02 in the patient airway while measuring Airway and PEEP pressure. 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/K031814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031814: STATCO2METER, Model 10-55372.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031814
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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