510(k) · Cleared
ClearedNordiwell Surgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Combat Protective Equipment Co., Ltd. · FXX Mask, Surgical
Cleared on Mar 9, 2021 as substantially equivalent to K202615 (Changzhou Combat Protective Equipment Co., Ltd., 2020) after a 46-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Mar 9, 2021
- Review
- 46 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911334 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK911334 Mask, Surgical ApparelThai Hospital Products Co., Ltd. · 1991
- 2 generations backK200847 Surgical Face MaskMexpo International, Inc. · 2020
- 1 generation backK202615 Nordiwell Medical Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2020
- This deviceK210181 Nordiwell Surgical Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911334 | Mask, Surgical Apparel | Thai Hospital Products Co., Ltd. | 1991 | — |
| −2 | K200847 | Surgical Face Mask | Mexpo International, Inc. | 2020 | — |
| −1 | K202615 | Nordiwell Medical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2020 | — |
| 0 (this device) | K210181 | Nordiwell Surgical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2021 | — |
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 |
|---|---|---|---|
| * | K202615 | Nordiwell Medical Face MaskSummary page 4…cation: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital 3. Legally Marketed Primary Predicate Device Nordiwell Medical Face Mask (K202615) 4. Indication for use When properly worn, the surgical face masks are intended to protect both patient and… | 2020 |
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 30 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
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?
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210181: Nordiwell Surgical Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210181
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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