510(k) · Cleared
ClearedDisposable Surgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Zhushi Pharmaceutical Group Co., Ltd. · FXX Mask, Surgical
Cleared on Aug 4, 2021 as substantially equivalent to K203200 (Guangdong Haiou Medical Apparatus Co., Ltd., 2021) after a 154-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- Aug 4, 2021
- Review
- 154 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K874608 (1987). 12 ancestors in all, the oldest K801036 (1980). No later device cites it as a predicate yet.
- Root · 9 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 5 generations between
- 3 generations backK111559 Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011
- 2 generations backK201137 Asept Surgical Face MaskPfm Medical, Inc. · 2020
- 1 generation backK203200 Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd. · 2021
- This deviceK210643 Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 8 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 7 generations backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
- 6 generations backK040333 Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach)…Valumax Intl., Inc. · 2004
- 5 generations backK051291 Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · Recalled
- 4 generations backK061864 Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540…Dukal Corp. · 2006
- 3 generations backK111559 Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011
- 2 generations backK201137 Asept Surgical Face MaskPfm Medical, Inc. · 2020
- 1 generation backK203200 Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd. · 2021
- This deviceK210643 Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −8 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −7 | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… | Crosstex Intl. | 2002 | — |
| −6 | K040333 | Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or… | Valumax Intl., Inc. | 2004 | — |
| −5 | K051291 | Non-Sterile Surgical Mask | A.R. Medicom, Inc. | 2005 | 5 |
| −4 | K061864 | Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with… | Dukal Corp. | 2006 | — |
| −3 | K111559 | Surgical Masks | Shanghai Neo-Medical Import & Export Co., Ltd. | 2011 | — |
| −2 | K201137 | Asept Surgical Face Mask | Pfm Medical, Inc. | 2020 | — |
| −1 | K203200 | Disposable Medical Surgical Face Mask | Guangdong Haiou Medical Apparatus Co., Ltd. | 2021 | — |
| 0 (this device) | K210643 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K203200 | Disposable Medical Surgical Face Mask Cleared while this submission was under review Summary page 5…tus Co., Ltd. Page 1 of 6 510(k) Summary Device: Disposable Medical Surgical Face Mask 510(k) number: K203200 Classification name: Mask, Surgical Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II… | 2021 |
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 10 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 12 ancestors have a recall of any class.
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?
The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This 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(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/K210643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210643: Disposable 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/K210643
Report an extraction error
Are you the manufacturer?
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