510(k) · Cleared
ClearedPanoramic Oxygen Mask (POM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pom Medical, LLC · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Apr 19, 2018 as substantially equivalent to K133806 (Monitor Mask, Inc., 2013) after a 258-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Apr 19, 2018
- Review
- 258 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971229 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971229 Capnoxygen MaskMedsys, Inc. · 1997
- 1 generation backK133806 M1 Capnography MaskMonitor Mask, Inc. · 2013
- This deviceK172365 Panoramic Oxygen Mask (POM)Pom Medical, LLC · 2018
- Descendant · cites it directly · 0 of its ownK222511 Oxy2ProSouthmedic, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK220533 Endoscopy Oxygen MaskEngineered Medical Systems, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971229 | Capnoxygen Mask | Medsys, Inc. | 1997 | — |
| −1 | K133806 | M1 Capnography Mask | Monitor Mask, Inc. | 2013 | — |
| 0 (this device) | K172365 | Panoramic Oxygen Mask (POM) | Pom Medical, LLC | 2018 | — |
| +1 | K222511 | Oxy2Pro | Southmedic, Inc. | 2023 | — |
| +1 | K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133806 | M1 Capnography MaskSummary page 4…rocode – CCK Analyzer, gas, carbon-dioxide, gaseous phase Class II Predicate Device: K133806 – Monitored Mask, M1 Capnography mask CapnoVue Scope Device Description: The Panoramic Oxygen… | 2013 |
What descends from it? (2)
2 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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 16.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K222511 (Southmedic, Inc., 2023) has gone furthest, with 0 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. 2018, 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 Panoramic Oxygen Mask (POM) is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172365: Panoramic Oxygen Mask (POM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172365
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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