510(k) · Cleared
ClearedSurgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mexpo International, Inc. · FXX Mask, Surgical
Cleared on Apr 23, 2020 as substantially equivalent to K911334 (Thai Hospital Products Co., Ltd., 1991) after a 23-day review. Its family tree reaches back 1 generation to 1991. 14 later devices descend from it.
- Decided
- Apr 23, 2020
- Review
- 23 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911334 (1991). 14 later devices descend from it, 11 citing it directly.
- Root · 1 generation backK911334 Mask, Surgical ApparelThai Hospital Products Co., Ltd. · 1991
- This deviceK200847 Surgical Face MaskMexpo International, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK211105 Ear-Friendly MaskRay Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK212398 Surgical Face Mask (Non-sterile)Hubei Kimsoul Industrial Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK202615 Nordiwell Medical Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK221682 Ideal Med Pro 3-Ply Disposable Face MaskJsn Holdings, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK222335 Surgical MaskLuoyang Sunmed Devices Co., Ltd. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K211105Ear-Friendly MaskRay Co., Ltd. · 2021 · cites it directly2descendants
- K212398Surgical Face Mask (Non-sterile)Hubei Kimsoul Industrial Co., Ltd. · 2021 · 2 generations on1descendant
- K202615Nordiwell Medical Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2020 · cites it directly1descendant
- K221682Ideal Med Pro 3-Ply Disposable Face MaskJsn Holdings, LLC · 2023 · cites it directly0descendants
- K222335Surgical MaskLuoyang Sunmed Devices Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911334 | Mask, Surgical Apparel | Thai Hospital Products Co., Ltd. | 1991 | — |
| 0 (this device) | K200847 | Surgical Face Mask | Mexpo International, Inc. | 2020 | — |
| +1 | K211105 | Ear-Friendly Mask | Ray Co., Ltd. | 2021 | — |
| +2 | K212398 | Surgical Face Mask (Non-sterile) | Hubei Kimsoul Industrial Co., Ltd. | 2021 | — |
| +1 | K202615 | Nordiwell Medical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2020 | — |
| +1 | K221682 | Ideal Med Pro 3-Ply Disposable Face Mask | Jsn Holdings, LLC | 2023 | — |
| +3 | K222335 | Surgical Mask | Luoyang Sunmed Devices Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 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 |
|---|---|---|---|
| * | K911334 | Mask, Surgical ApparelSummary page 4…ace Mask, Apparel Classification : Class II Product Code : FXX Regulation Number : 21 CFR 878.4040 4. Predicate Device 510K Number : K911334 - Thai Hospital Products Co. Ltd. Device Name : Mask, Surgical Apparel 5. Intended Use When properly worn, the… | 1991 |
What descends from it? (14)
See all 1411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211105 | Ear-Friendly Mask | 2021 | 2 |
| K202615 | Nordiwell Medical Face Mask | 2020 | 1 |
| K221682 | Ideal Med Pro 3-Ply Disposable Face Mask | 2023 | 0 |
| K212203 | Dong Hai Xiang Surgical Mask | 2022 | 0 |
| K213894 | DWFritz ASM2000 | 2022 | 0 |
| K210679 | Medical Face Mask | 2022 | 0 |
| K211260 | Sheng Jing Tang Surgical Mask | 2022 | 0 |
| K212460 | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) | 2021 | 0 |
| K210878 | Surgical Face Mask (Model: CM2006, CM2008, A88) | 2021 | 0 |
| K203756 | Disposable Surgical 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?
- Its one ancestor has no recall.
- Of its descendants, K211105 (Ray Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
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 airborne particles. This device is non sterile and for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200847: 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/K200847
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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