510(k) · Cleared
ClearedM1 Capnography Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monitor Mask, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Dec 31, 2013 as substantially equivalent to K971229 (Medsys, Inc., 1997) after a 15-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Dec 31, 2013
- Review
- 15 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971229 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK971229 Capnoxygen MaskMedsys, Inc. · 1997
- This deviceK133806 M1 Capnography MaskMonitor Mask, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK172365 Panoramic Oxygen Mask (POM)Pom Medical, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK222511 Oxy2ProSouthmedic, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK220533 Endoscopy Oxygen MaskEngineered Medical Systems, Inc. · 2022
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 | K971229 | Capnoxygen Mask | Medsys, Inc. | 1997 | — |
| 0 (this device) | K133806 | M1 Capnography Mask | Monitor Mask, Inc. | 2013 | — |
| +1 | K172365 | Panoramic Oxygen Mask (POM) | Pom Medical, LLC | 2018 | — |
| +2 | K222511 | Oxy2Pro | Southmedic, Inc. | 2023 | — |
| +2 | K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K971229 | Capnoxygen MaskSummary page 7…manufactured and tested in a non-clinical setting by Monitor Mask and when compared to the predicate device manufactured by Medlsys (Southmedic) previously cleared under K971229, demonstrates that the subject device is as safe, as effective, and performs at least as safely and effectively as the predicate… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172365 | Panoramic Oxygen Mask (POM) | 2018 | 2 |
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. 2013, 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 M1 Capnagraphy Mask is a single-use device intended for delivering supplemental oxygen and monitoring exhaled carbon dioxide in non-intubated spontaneously breathing patients. Standard oxygen tubing and two female luer ports for gas sample line attachment are included.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133806: M1 Capnography Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133806
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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