510(k) · Cleared
ClearedCapnoxygen Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsys, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Sep 23, 1997 after a 174-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Sep 23, 1997
- Review
- 174 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK971229 Capnoxygen MaskMedsys, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK133806 M1 Capnography MaskMonitor Mask, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK172365 Panoramic Oxygen Mask (POM)Pom Medical, LLC · 2018
- Descendant · 3 generations on · 0 of its ownK222511 Oxy2ProSouthmedic, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK220533 Endoscopy Oxygen MaskEngineered Medical Systems, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK131339 CapnomaskMediplus, Ltd. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133806M1 Capnography MaskMonitor Mask, Inc. · 2013 · cites it directly3descendants
- K172365Panoramic Oxygen Mask (POM)Pom Medical, LLC · 2018 · 2 generations on2descendants
- K222511Oxy2ProSouthmedic, Inc. · 2023 · 3 generations on0descendants
- K220533Endoscopy Oxygen MaskEngineered Medical Systems, Inc. · 2022 · 3 generations on0descendants
- K131339CapnomaskMediplus, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971229 | Capnoxygen Mask | Medsys, Inc. | 1997 | — |
| +1 | K133806 | M1 Capnography Mask | Monitor Mask, Inc. | 2013 | — |
| +2 | K172365 | Panoramic Oxygen Mask (POM) | Pom Medical, LLC | 2018 | — |
| +3 | K222511 | Oxy2Pro | Southmedic, Inc. | 2023 | — |
| +3 | K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | 2022 | — |
| +1 | K131339 | Capnomask | Mediplus, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2013 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | — | Jemsdal A-221 Capnographic Mask Named without a submission number |
What descends from it? (6)
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?
- Of its descendants, K133806 (Monitor Mask, Inc., 2013) has gone furthest, with 3 descendants of its own.
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 CAPNOXYGEN mask is a medium concentration single-use mask intended to be used for the delivery of supplemental oxygen and monitoring breathing by sampling exhaled carbon dioxide. Standard connectors for the oxygen tubing and a standard female Luer connector for the gas sample line are provided. The mask is intended to be used for monitoring non-intubated patients who are breathing spontaneously.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971229: Capnoxygen Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971229
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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