510(k) · Cleared
ClearedMaxCap Ped and MaxCap Neo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxtec, LLC · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on May 23, 2019 as substantially equivalent to K031411 (Mercury Medical, 2003) and 1 other predicate after a 266-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- May 23, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K950387 (1995). 6 ancestors in all, the oldest K944400 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK950387 GeminiSpegas Industries, Ltd. · 1995
- 3 generations backK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
- 2 generations backK024300 Microcap Plus/NPB-75Oridion Medical 1987, Ltd. · 2003
- 1 generation backK083056 Neo-Stat CO2 <KGMercury Medical · 2009
- This deviceK182362 MaxCap Ped and MaxCap NeoMaxtec, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950387 | Gemini | Spegas Industries, Ltd. | 1995 | — |
| −3 | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | Spegas Industries, Ltd. | 1997 | — |
| −2 | K024300 | Microcap Plus/NPB-75 | Oridion Medical 1987, Ltd. | 2003 | — |
| −1 | K083056 | Neo-Stat CO2 <KG | Mercury Medical | 2009 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K031411 | Mini STATCO2 CO2 Detector, Model 10-55371Summary page 4…Class II Predicate Devices: Mercury Medical - Mercury Medical Mini Stat CO2 End Tidal CO2 - K031411 Mercury Medical - Mercury Medical NeoStatCO2 <Kg - K0… | 2003 |
| * | K083056 | Neo-Stat CO2 <KGSummary page 4…Tidal CO2 - K031411 Mercury Medical - Mercury Medical NeoStatCO2 <Kg - K083056 Reference device: Maxtec - FloCap CO2 Indicator - K133540 Device Description The proposed MaxCap Neo and M… | 2009 |
| † | K133540 | Flocap | 2014 |
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 24 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 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. 2019, 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 Maxtec MaxCap Neo and MaxCap Ped are 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.
Patient Population:
MaxCap Neo is intended for use with neonates and infants 250g to 6kg.
MaxCap Ped is intended for use with pediatric patients 1kg to 15kg
Environment of Use:
Hospital, sub-acute, pre-hospital, transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182362: MaxCap Ped and MaxCap Neo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182362
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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