510(k) · Cleared
ClearedMini STATCO2 CO2 Detector, Model 10-55371
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 Jul 30, 2003 as substantially equivalent to K944400 (Nellcor, Inc., 1994) after an 86-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Jul 30, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944400 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK944400 Pedi-CapNellcor, Inc. · 1994 · Recalled
- This deviceK031411 Mini STATCO2 CO2 Detector, Model 10-55371Mercury Medical · 2003
- Descendant · cites it directly · 1 of its ownK083056 Neo-Stat CO2 <KGMercury Medical · 2009
- Descendant · cites it directly · 0 of its ownK182362 MaxCap Ped and MaxCap NeoMaxtec, LLC · 2019
- Descendant · cites it directly · 0 of its ownK112840 Capnodura Combi & Capnodura Pedi CO2 DetectorSeebreath AB · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944400 | Pedi-Cap | Nellcor, Inc. | 1994 | 1 |
| 0 (this device) | K031411 | Mini STATCO2 CO2 Detector, Model 10-55371 | Mercury Medical | 2003 | — |
| +1 | K083056 | Neo-Stat CO2 <KG | Mercury Medical | 2009 | — |
| +1 | K182362 | MaxCap Ped and MaxCap Neo | Maxtec, LLC | 2019 | — |
| +1 | K112840 | Capnodura Combi & Capnodura Pedi CO2 Detector | Seebreath AB | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K944400 | Pedi-CapSummary page 1…Class 11, CCK, 21 CFR 868.1400 Classification Name: Analyzer, Gas, Carbon Dioxide, Gaseous Phase Device: Mini StatC02" Detector Predicate Devices: Nellcor Pedi-CAP" (K944400) Device Description: The Mercury Medical Mini StatCOzTMuses the same technology as the Nellcor Pedi- CAPTM(K944400). The Mini S… | 1994 |
| † | K000520 | C-IT | 2000 |
What descends from it? (3)
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 Mini StatCO2TM End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 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/K031411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031411: Mini STATCO2 CO2 Detector, Model 10-55371.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031411
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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