510(k) · Cleared
ClearedNeo-Stat CO2 <KG
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 Feb 23, 2009 as substantially equivalent to K031411 (Mercury Medical, 2003) and 2 other predicates after a 132-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Feb 23, 2009
- Review
- 132 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K950387 (1995). 5 ancestors in all, the oldest K944400 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK950387 GeminiSpegas Industries, Ltd. · 1995
- 2 generations backK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
- 1 generation backK024300 Microcap Plus/NPB-75Oridion Medical 1987, Ltd. · 2003
- This deviceK083056 Neo-Stat CO2 <KGMercury Medical · 2009
- Descendant · cites it directly · 0 of its ownK182362 MaxCap Ped and MaxCap NeoMaxtec, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K182362MaxCap Ped and MaxCap NeoMaxtec, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950387 | Gemini | Spegas Industries, Ltd. | 1995 | — |
| −2 | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | Spegas Industries, Ltd. | 1997 | — |
| −1 | K024300 | Microcap Plus/NPB-75 | Oridion Medical 1987, Ltd. | 2003 | — |
| 0 (this device) | K083056 | Neo-Stat CO2 <KG | Mercury Medical | 2009 | — |
| +1 | K182362 | MaxCap Ped and MaxCap Neo | Maxtec, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K031411 | Mini STATCO2 CO2 Detector, Model 10-55371Summary page 1…CCK - carbon dioxide gas analyzer Device: Neo-StatCO 2<Kg Predicate Devices: Mercury Medical - Mini-StatCO 2 - K03 141 1 Nellcor - Pedi-CAPTM - K944400 Oridion - MicroCap - K02… | 2003 |
| * | K944400 | Pedi-CapSummary page 1…Neo-StatCO 2<Kg Predicate Devices: Mercury Medical - Mini-StatCO 2 - K03 141 1 Nellcor - Pedi-CAPTM - K944400 Oridion - MicroCap - K024300 Device Description: Neo-StatCO 2 <Kg is a colorimetric breath… | 1994 |
| * | K024300 | Microcap Plus/NPB-75Summary page 1…Mercury Medical - Mini-StatCO 2 - K03 141 1 Nellcor - Pedi-CAPTM - K944400 Oridion - MicroCap - K024300 Device Description: Neo-StatCO 2 <Kg is a colorimetric breath indicator for visualization of exhaled CO 2. It is designed to con… | 2003 |
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 |
|---|---|---|---|
| K182362 | MaxCap Ped and MaxCap Neo | 2019 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K182362 (Maxtec, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031411.
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. 2009, 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 Neo-StatCO₂ <Kg is indicated 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. Intended for use with neonate and infant patients from 250g to 6 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083056: Neo-Stat CO2 <KG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083056
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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