510(k) · Cleared
ClearedNordiwell Medical 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 Dec 31, 2020 as substantially equivalent to K200847 (Mexpo International, Inc., 2020) after a 113-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Dec 31, 2020
- Review
- 113 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911334 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK911334 Mask, Surgical ApparelThai Hospital Products Co., Ltd. · 1991
- 1 generation backK200847 Surgical Face MaskMexpo International, Inc. · 2020
- This deviceK202615 Nordiwell Medical Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK210181 Nordiwell Surgical Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210181Nordiwell Surgical Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911334 | Mask, Surgical Apparel | Thai Hospital Products Co., Ltd. | 1991 | — |
| −1 | K200847 | Surgical Face Mask | Mexpo International, Inc. | 2020 | — |
| 0 (this device) | K202615 | Nordiwell Medical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2020 | — |
| +1 | K210181 | Nordiwell Surgical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K200847 | Surgical Face MaskSummary page 4…ation Number: 21 CFR 878.4040 Review Panel: General Hospital 3. Legally Marketed Primary Predicate Device Product name: Avianz® Surgical Face Mask 510(k) Number: K200847 Product Code: FXX Manufacture: MEXPO INTERNATIONAL INC. 1 4… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210181 | Nordiwell Surgical Face Mask | 2021 | 0 |
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 29 years and passes through 3 companies; a new generation was cleared every 28.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210181 (Changzhou Combat Protective Equipment Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K200847.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K202615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202615: Nordiwell Medical 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/K202615
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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