FDA product code FYC: Gown, Isolation, Surgical
FYC is the FDA product code for gown, isolation, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 68 510(k) submissions under FYC, 15 in the last five years, from 58 different applicants. The average 510(k) review took 180 days (median 144); 245 days on average over the last three years. FDA has posted 2 recalls for FYC devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Gown, Isolation, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for FYC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 347 |
| 2018 | 1 | 266 |
| 2020 | 1 | 339 |
| 2021 | 7 | 169 |
| 2022 | 10 | 283 |
| 2023 | 4 | 126 |
| 2024 | 1 | 245 |
Compare with all 510(k) review times · Search every FYC clearance
Top FYC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Threshold Industries, Inc. | 4 | 1995-09-25 |
| American Hospital Supply Corp. | 3 | 1980-05-23 |
| Hubei Xinxin Non-Woven Co., Ltd. | 2 | 2022-10-11 |
| Kentron Health Care, Inc. | 2 | 1997-09-19 |
| Amsco Sterile Recoveries, Inc. | 2 | 1994-06-10 |
53 more applicants have FYC clearances. See the full list in Caduvo.
Most recent FYC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232849 | Owens & Minor (O&M) Halyard, Inc. | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) | 2024-05-16 | 245 |
| K230135 | Copioumed International, Inc. | Copioumed Chemotherapy Isolation Gown | 2023-10-04 | 259 |
| K223467 | Nanning Tecbod Biological Technology Co., Ltd. | Disposable Isolation Gown | 2023-02-10 | 85 |
| K223304 | Xiamen Probtain Medical Technology Co., Ltd. | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | 2023-02-08 | 104 |
| K223411 | Xiamen Probtain Medical Techology Co., Ltd. | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | 2023-01-04 | 56 |
Recalls for FYC devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-11-01.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code FYC?
FYC is the FDA product code for gown, isolation, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is FYC?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code FYC?
Across 68 cleared submissions the average was 180 days from receipt to decision (median 144).
Which companies have the most FYC clearances?
American Threshold Industries, Inc. (4); American Hospital Supply Corp. (3); Hubei Xinxin Non-Woven Co., Ltd. (2); Kentron Health Care, Inc. (2); Amsco Sterile Recoveries, Inc. (2).
Have FYC devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2024-11-01.
Next steps
- Run an FDA pathway report with predicate devices for product code FYC
- Run a recall and safety report across every FYC manufacturer
- Watch product code FYC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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