510(k) · Cleared
ClearedMedical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhende Medical Co., Ltd. · FXX Mask, Surgical
Cleared on Dec 3, 2020 as substantially equivalent to K110455 (Kimberly-Clark Corp., 2011) after a 162-day review. Its family tree reaches back 4 generations to 1987. 5 later devices descend from it.
- Decided
- Dec 3, 2020
- Review
- 162 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K874608 (1987). 6 ancestors in all, the oldest K801036 (1980). 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 3 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 2 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 1 generation backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- This deviceK201729 Medical MaskZhende Medical Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK214087 Medical Face MaskHubei Medlink Healthcare Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK222809 Medical Disposable Face MasksAnqing Mayfield Medical Limited · 2023
- Descendant · 3 generations on · 0 of its ownK240258 Disposable Medical Face Mask (M643BE)Makrite Industries, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK203012 Surgical MaskCustomfab, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK202708 Surgical Face MasksIntco Medical (Hk) Co., Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K214087Medical Face MaskHubei Medlink Healthcare Co., Ltd. · 2022 · cites it directly2descendants
- K222809Medical Disposable Face MasksAnqing Mayfield Medical Limited · 2023 · 2 generations on1descendant
- K240258Disposable Medical Face Mask (M643BE)Makrite Industries, Inc. · 2024 · 3 generations on0descendants
- K203012Surgical MaskCustomfab, Inc. · 2021 · cites it directly0descendants
- K202708Surgical Face MasksIntco Medical (Hk) Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −3 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −2 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −1 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| 0 (this device) | K201729 | Medical Mask | Zhende Medical Co., Ltd. | 2020 | — |
| +1 | K214087 | Medical Face Mask | Hubei Medlink Healthcare Co., Ltd. | 2022 | — |
| +2 | K222809 | Medical Disposable Face Masks | Anqing Mayfield Medical Limited | 2023 | — |
| +3 | K240258 | Disposable Medical Face Mask (M643BE) | Makrite Industries, Inc. | 2024 | — |
| +1 | K203012 | Surgical Mask | Customfab, Inc. | 2021 | — |
| +1 | K202708 | Surgical Face Masks | Intco Medical (Hk) Co., Ltd. | 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 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face MasksSummary page 4…ation Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel C. Predicate device: K110455 Kimberly-Clark KC100 Mask Kimberly-Clark D. Intended use of the device: The Medical Masks are intended to be worn to protect bot… | 2011 |
What descends from it? (5)
3 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 5 companies; a new generation was cleared every 9.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K214087 (Hubei Medlink Healthcare Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 18 other devices also cite its predicate K110455.
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 Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of
microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201729 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201729: Medical Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201729
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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