510(k) · Cleared
ClearedPOSE™ Health Care Surgical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
America'S Supply Chains · FXX Mask, Surgical
Cleared on Nov 1, 2022 as substantially equivalent to K172500 (Yts Global, Inc., 2018) after an 8-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Nov 1, 2022
- Review
- 8 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K063023 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK063023 3M Health Care Particulate Respirator and Surgical Mask, Model 18703M Company · 2007
- 2 generations backK121069 3M Vflex Health Care Particulate Respirator and Surgical Mask3M Company · 2013
- 1 generation backK172500 Technoweb Surgical MaskYts Global, Inc. · 2018
- This deviceK223270 POSE™ Health Care Surgical MaskAmerica'S Supply Chains · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K063023 | 3M Health Care Particulate Respirator and Surgical Mask, Model 1870 | 3M Company | 2007 | — |
| −2 | K121069 | 3M Vflex Health Care Particulate Respirator and Surgical Mask | 3M Company | 2013 | — |
| −1 | K172500 | Technoweb Surgical Mask | Yts Global, Inc. | 2018 | — |
| 0 (this device) | K223270 | POSE™ Health Care Surgical Mask | America'S Supply Chains | 2022 | — |
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 FXX? 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 FXX device
- #1 K201479 DemeMASKscore 40.2 · 6 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 |
|---|---|---|---|
| * | K172500 | Technoweb Surgical MaskSummary page 4…FXX III. PREDICATE DEVICE Predicate Manufacturer: YTS GLOBAL INC Predicate Trade Name: Technoweb Surgical Mask Predicate 510(k): K172500 Device Classification Name: mask, surgical Device Name: Technoweb Surgical Mask Regulatory Class:… | 2018 |
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 15 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K172500.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FXX
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FXX
123in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FXX
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FXX
11in 2025
MAUDE reports naming product code FXX, 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 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 7 | 144 | 0 | 9 |
| 2011 | 6 | 137 | 0 | 8 |
| 2012 | 1 | — | 0 | 22 |
| 2013 | 3 | 219 | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 5 | 298 | 0 | 14 |
| 2016 | 5 | 268 | 0 | 16 |
| 2017 | 1 | — | 0 | 45 |
| 2018 | 3 | 119 | 0 | 21 |
| 2019 | 4 | 124 | 2 | 23 |
| 2020 | 27 | 113 | 0 | 60 |
| 2021 | 218 | 162 | 0 | 67 |
| 2022 | 91 | 113 | 0 | 21 |
| 2023 | 22 | 139 | 1 | 21 |
| 2024 | 15 | 263 | 2 | 21 |
| 2025 | 6 | 123 | 0 | 11 |
| 2026 | 5 | 142 | 0 | — |
What is it indicated for?
The POSE™ Health Care Surgical Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223270: POSE™ Health Care Surgical Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223270
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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