510(k) · Cleared
ClearedMask, Surgical Apparel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thai Hospital Products Co., Ltd. · FXX Mask, Surgical
Cleared on Aug 29, 1991 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Aug 29, 1991
- Review
- 156 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK911334 Mask, Surgical ApparelThai Hospital Products Co., Ltd. · 1991
- Descendant · cites it directly · 14 of its ownK200847 Surgical Face MaskMexpo International, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK211105 Ear-Friendly MaskRay Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK212398 Surgical Face Mask (Non-sterile)Hubei Kimsoul Industrial Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK202615 Nordiwell Medical Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK221682 Ideal Med Pro 3-Ply Disposable Face MaskJsn Holdings, LLC · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K200847Surgical Face MaskMexpo International, Inc. · 2020 · cites it directly14descendants
- K211105Ear-Friendly MaskRay Co., Ltd. · 2021 · 2 generations on2descendants
- K212398Surgical Face Mask (Non-sterile)Hubei Kimsoul Industrial Co., Ltd. · 2021 · 3 generations on1descendant
- K202615Nordiwell Medical Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2020 · 2 generations on1descendant
- K221682Ideal Med Pro 3-Ply Disposable Face MaskJsn Holdings, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911334 | Mask, Surgical Apparel | Thai Hospital Products Co., Ltd. | 1991 | — |
| +1 | K200847 | Surgical Face Mask | Mexpo International, Inc. | 2020 | — |
| +2 | K211105 | Ear-Friendly Mask | Ray Co., Ltd. | 2021 | — |
| +3 | K212398 | Surgical Face Mask (Non-sterile) | Hubei Kimsoul Industrial Co., Ltd. | 2021 | — |
| +2 | K202615 | Nordiwell Medical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2020 | — |
| +2 | K221682 | Ideal Med Pro 3-Ply Disposable Face Mask | Jsn Holdings, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200847 | Surgical Face Mask | 2020 | 14 |
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?
- Of its descendants, K200847 (Mexpo International, Inc., 2020) has gone furthest, with 14 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.
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 | — |
https://510kreport.com/device/K911334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911334: Mask, Surgical Apparel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911334
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026