510(k) · Cleared
ClearedSurgical Face Mask (Non-sterile)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hubei Kimsoul Industrial Co., Ltd. · FXX Mask, Surgical
Cleared on Dec 15, 2021 as substantially equivalent to K211105 (Ray Co., Ltd., 2021) after a 135-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Dec 15, 2021
- Review
- 135 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911334 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK911334 Mask, Surgical ApparelThai Hospital Products Co., Ltd. · 1991
- 2 generations backK200847 Surgical Face MaskMexpo International, Inc. · 2020
- 1 generation backK211105 Ear-Friendly MaskRay Co., Ltd. · 2021
- This deviceK212398 Surgical Face Mask (Non-sterile)Hubei Kimsoul Industrial Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK222335 Surgical MaskLuoyang Sunmed Devices Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222335Surgical MaskLuoyang Sunmed Devices Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911334 | Mask, Surgical Apparel | Thai Hospital Products Co., Ltd. | 1991 | — |
| −2 | K200847 | Surgical Face Mask | Mexpo International, Inc. | 2020 | — |
| −1 | K211105 | Ear-Friendly Mask | Ray Co., Ltd. | 2021 | — |
| 0 (this device) | K212398 | Surgical Face Mask (Non-sterile) | Hubei Kimsoul Industrial Co., Ltd. | 2021 | — |
| +1 | K222335 | Surgical Mask | Luoyang Sunmed Devices Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K211105 | Ear-Friendly MaskSummary page 4…code FXX Regulation No. 21 CFR 878.4040 3. Legally Marketed Predicate Device Trade Name Ear-Friendly Mask 510(k) Number K211105 Product Code FXX Manufacturer RAY Co., Ltd 4. Legally Marketed Reference Device Trade Nam… | 2021 |
| † | K202341 | Disposable Surgical Mask | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222335 | Surgical Mask | 2022 | 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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K222335 (Luoyang Sunmed Devices Co., Ltd., 2022) has gone furthest, with 0 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. 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 masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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 as stated in the FDA summary.
https://510kreport.com/device/K212398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212398: Surgical Face Mask (Non-sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212398
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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