510(k) · Cleared
ClearedDisposable Surgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Bida Medical Technology Co., Ltd. · FXX Mask, Surgical
Cleared on Apr 23, 2021 as substantially equivalent to K160269 (San-M Package Co., Ltd., 2016) and 1 other predicate after a 245-day review. Its family tree reaches back 7 generations to 1987.
- Decided
- Apr 23, 2021
- Review
- 245 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K874608 (1987). 10 ancestors in all, the oldest K801036 (1980). No later device cites it as a predicate yet.
- Root · 7 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 6 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 5 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 4 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 3 generations backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- 2 generations backK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
- 1 generation backK191355 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant…3M Healthcare · 2019
- This deviceK202387 Disposable Surgical Face MaskGuangdong Bida Medical Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −6 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −5 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −4 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −3 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| −2 | K131879 | KC 300 Surgical Mask | Kimberly-Clark Corp. | 2013 | 1 |
| −1 | K191355 | 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure… | 3M Healthcare | 2019 | — |
| 0 (this device) | K202387 | Disposable Surgical Face Mask | Guangdong Bida Medical Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K160269 | Surgical Face Masks (Ear loops and Tie-on)Summary page 5…Information Predicate Device 1: Sponsor: San-M Package Co. Ltd. Trade Name: Surgical Face Masks (Ear loops and Tie-on) Classification Name: Mask, Surgical 510(K) Number: K160269 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: 11 Predicate Device 2: Sponsor:… | 2016 |
| * | K191355 | 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure MaskSummary page 5…gulatory Class: 11 Predicate Device 2: Sponsor: 3M Health Care Trade Name: 3MTM Hight Fluid-Resistant Procedure Mask Classification Name: Mask, Surgical 510(K) Number: K191355 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: 11 5. Intended Use / Indicatio… | 2019 |
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 7 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 38 other devices also cite its predicate K160269.
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?
Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of
microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection
control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable
devices provide 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/K202387 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202387: Disposable Surgical Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202387
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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