510(k) · Cleared
ClearedAMD Ritmed AssureWear VersaGown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amd Medicom, Inc. · FYC Gown, Isolation, Surgical
Cleared on Jan 17, 2020 as substantially equivalent to K160339 (Cardinal Health200, LLC, 2016) after a 339-day review. Its family tree reaches back 2 generations to 1995. 6 later devices descend from it.
- Decided
- Jan 17, 2020
- Review
- 339 days
- Class
- Class II
- Product code
- FYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952116 (1995). 6 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK952116 Cover GownAmerican Threshold Industries, Inc. · 1995
- 1 generation backK160339 Cardinal Health Isolation GownCardinal Health200, LLC · 2016 · Recalled
- This deviceK190306 AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK203415 Surgical Isolation GownYanbian Pacific Textile Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK230135 Copioumed Chemotherapy Isolation GownCopioumed International, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK210414 CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU…Medtecs (Taiwan) Corp. · 2022
- Descendant · cites it directly · 0 of its ownK214116 AAMI4 Isolation GownHubei Xinxin Non-Woven Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK212422 Disposable Surgical Isolation GownCrown Name Disposable Hygiene Products Fty., Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K203415Surgical Isolation GownYanbian Pacific Textile Co., Ltd. · 2021 · cites it directly1descendant
- K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc. · 2023 · cites it directly0descendants
- K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with…Medtecs (Taiwan) Corp. · 2022 · cites it directly0descendants
- K214116AAMI4 Isolation GownHubei Xinxin Non-Woven Co., Ltd. · 2022 · cites it directly0descendants
- K212422Disposable Surgical Isolation GownCrown Name Disposable Hygiene Products Fty., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952116 | Cover Gown | American Threshold Industries, Inc. | 1995 | — |
| −1 | K160339 | Cardinal Health Isolation Gown | Cardinal Health200, LLC | 2016 | 2 |
| 0 (this device) | K190306 | AMD Ritmed AssureWear VersaGown | Amd Medicom, Inc. | 2020 | — |
| +1 | K203415 | Surgical Isolation Gown | Yanbian Pacific Textile Co., Ltd. | 2021 | — |
| +1 | K230135 | Copioumed Chemotherapy Isolation Gown | Copioumed International, Inc. | 2023 | — |
| +1 | K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable… | Medtecs (Taiwan) Corp. | 2022 | — |
| +1 | K214116 | AAMI4 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022 | — |
| +2 | K212422 | Disposable Surgical Isolation Gown | Crown Name Disposable Hygiene Products Fty., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 4 | 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 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 K210785 Disposable Surgical Gownsscore 11.9 · 3 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 |
|---|---|---|---|
| * | K160339 | Cardinal Health Isolation GownSummary page 4…Class II Product Code: FYC Device Classification Name Gown, Isolation, Surgical Predicate Device Cardinal Health™ Isolation Gowns (K160339) Device Description AMD Ritmed AssureWear™ VersaGown isolation gown is intended to be worn by healthcare personnel to protect… | 2016 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 3 companies; a new generation was cleared every 20.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K203415 (Yanbian Pacific Textile Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K160339.
How does its category compare?
All FYC devicesFYC Gown, Isolation, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 | — |
What is it indicated for?
AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities…
Read the full statement (126 words)
AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). AMD Ritmed AssureWear™ VersaGown is a single use, non-sterile disposable medical device and not intended for use in operating rooms. The medical device will be available in 18 models in large and X-large sizes.
Flexneck Models Flexneck Plus Models Tie Models
A69964 A69933 A8300
A69965 A69934 A8301
A69966 A69935 A8302
A69967 A69936 A8303
A69968 A69937 A8304
A69969 A69938 A8305
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190306: AMD Ritmed AssureWear VersaGown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190306
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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