510(k) · Cleared
ClearedCover Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Threshold Industries, Inc. · FYC Gown, Isolation, Surgical
Cleared on Sep 5, 1995 after a 123-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 17 later devices descend from it.
- Decided
- Sep 5, 1995
- Review
- 123 days
- Class
- Class II
- Product code
- FYC
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 1 citing it directly.
- This deviceK952116 Cover GownAmerican Threshold Industries, Inc. · 1995
- Descendant · cites it directly · 16 of its ownK160339 Cardinal Health Isolation GownCardinal Health200, LLC · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK190306 AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK202310 Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical…Wildcat Ppe, LLC · 2021
- Descendant · 3 generations on · 3 of its ownK210785 Disposable Surgical GownsChongqing Litai Fashion Group Limited Company · 2021
- Descendant · 3 generations on · 1 of its ownK203415 Surgical Isolation GownYanbian Pacific Textile Co., Ltd. · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K160339Cardinal Health Isolation GownCardinal Health200, LLC · 2016 · cites it directly16descendants
- K190306AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. · 2020 · 2 generations on6descendants
- K202310Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full BackWildcat Ppe, LLC · 2021 · 2 generations on5descendants
- K210785Disposable Surgical GownsChongqing Litai Fashion Group Limited Company · 2021 · 3 generations on3descendants
- K203415Surgical Isolation GownYanbian Pacific Textile Co., Ltd. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952116 | Cover Gown | American Threshold Industries, Inc. | 1995 | — |
| +1 | K160339 | Cardinal Health Isolation Gown | Cardinal Health200, LLC | 2016 | 2 |
| +2 | K190306 | AMD Ritmed AssureWear VersaGown | Amd Medicom, Inc. | 2020 | — |
| +2 | K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation… | Wildcat Ppe, LLC | 2021 | — |
| +3 | K210785 | Disposable Surgical Gowns | Chongqing Litai Fashion Group Limited Company | 2021 | — |
| +3 | K203415 | Surgical Isolation Gown | Yanbian Pacific Textile Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 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 FYC? 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 FYC device
- #1 K190306 AMD Ritmed AssureWear VersaGownscore 14.0 · 2 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160339 | Cardinal Health Isolation Gown | 2016 | 16 |
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, K160339 (Cardinal Health200, LLC, 2016) has gone furthest, with 16 descendants of its own.
How does its category compare?
All FYC devicesFYC Gown, Isolation, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FYC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYC
95in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYC
3in 2025
MAUDE reports naming product code FYC, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 7 | 182 | 0 | 0 |
| 2022 | 10 | 229 | 0 | 0 |
| 2023 | 4 | 95 | 0 | 1 |
| 2024 | 1 | — | 2 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952116: Cover Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952116
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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