510(k) · Cleared
ClearedProtective Face Mask for Medical Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Shengquan New Material Co., Ltd. · FXX Mask, Surgical
Cleared on Sep 4, 2020 as substantially equivalent to K143287 (Halyard Health, Inc., 2015) after an 88-day review. Its family tree reaches back 6 generations to 1987. 4 later devices descend from it.
- Decided
- Sep 4, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K874608 (1987). 8 ancestors in all, the oldest K801036 (1980). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 5 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 4 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 3 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 2 generations backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- 1 generation backK143287 Fluidshield* Surgical Mask with Expanded ChamberHalyard Health, Inc. · 2015
- This deviceK201537 Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK212205 Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK202107 Medical Protective MaskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK223686 Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK212740 Puravita Medical Fold Flat Surgical MaskPuravita M, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K212205Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd. · 2021 · cites it directly1descendant
- K202107Medical Protective MaskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2021 · cites it directly1descendant
- K223686Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd. · 2023 · 2 generations on0descendants
- K212740Puravita Medical Fold Flat Surgical MaskPuravita M, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −5 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −4 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −3 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −2 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| −1 | K143287 | Fluidshield* Surgical Mask with Expanded Chamber | Halyard Health, Inc. | 2015 | — |
| 0 (this device) | K201537 | Protective Face Mask for Medical Use | Shandong Shengquan New Material Co., Ltd. | 2020 | — |
| +1 | K212205 | Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2021 | — |
| +1 | K202107 | Medical Protective Mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021 | — |
| +2 | K223686 | Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2023 | — |
| +2 | K212740 | Puravita Medical Fold Flat Surgical Mask | Puravita M, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 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 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 |
|---|---|---|---|
| * | K143287 | Fluidshield* Surgical Mask with Expanded ChamberSummary page 4…egulatory Class: Class II Product code: FXX Review Panel General Hospital III. Predicate Device 510(k) Number: K143287 Trade name: FLUIDSHIELD Surgical Mask with Expanded Chamber Common name: Surgical Mask Classification:… | 2015 |
What descends from it? (4)
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 33 years and passes through 7 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K212205 (Qinhuangdao Taizhi Medical Technology Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K143287.
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?
The Protective Face Mask for Medical Use is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201537: Protective Face Mask for Medical Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201537
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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