510(k) · Cleared
ClearednPro Surgical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Np Medical, Inc. · FXX Mask, Surgical
Cleared on Feb 9, 2021 as substantially equivalent to K142990 (Cardinal Health200, LLC, 2015) after a 96-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Feb 9, 2021
- Review
- 96 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K874608 (1987). 7 ancestors in all, the oldest K801036 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 4 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 3 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 2 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 1 generation backK142990 Insta-Gard Surgical and Procedure Face MaskCardinal Health200, LLC · 2015
- This deviceK203265 nPro Surgical MaskNp Medical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −4 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −3 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −2 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −1 | K142990 | Insta-Gard Surgical and Procedure Face Mask | Cardinal Health200, LLC | 2015 | — |
| 0 (this device) | K203265 | nPro Surgical Mask | Np Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 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 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 |
|---|---|---|---|
| * | K142990 | Insta-Gard Surgical and Procedure Face MaskSummary page 4…Mask Product Code: FXX Submission Type: Traditional 510(k) Predicate Name/510(k): Cardinal Health Insta-Guard® Procedure Mask/K142990 Device Description: The nPro surgical mask meets ASTM F2100-19 Level 1 performance requirements for bacterial filtration efficie… | 2015 |
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 34 years and passes through 6 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 nPro surgical masks are intended for operating room personnel and other general health care workers to protect both
patients and healthcare workers from the transfer of microorganisms, blood and body fluids and particulate materials.
nPro Surgical Masks are single use, disposable devices provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203265: nPro Surgical Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203265
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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