FDA product code FRO: Dressing, Wound, Drug
FRO is the FDA product code for dressing, wound, drug. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 708 510(k) submissions under FRO, 78 in the last five years, from 351 different applicants. The average 510(k) review took 187 days (median 148); 241 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 82 recalls for FRO devices, 38 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dressing, Wound, Drug |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for FRO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 23 | 164 |
| 2018 | 20 | 182 |
| 2019 | 16 | 256 |
| 2020 | 12 | 237 |
| 2021 | 8 | 226 |
| 2022 | 9 | 288 |
| 2023 | 18 | 328 |
| 2024 | 24 | 331 |
| 2025 | 11 | 194 |
| 2026 | 16 | 199 |
Compare with all 510(k) review times · Search every FRO clearance
Top FRO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Huizhou Foryou Medical Devices Co., Ltd. | 16 | 2025-11-19 |
| Convatec, A Division of E.R. Squibb & Sons | 13 | 2002-06-21 |
| Winner Medical Co., Ltd. | 12 | 2023-12-01 |
| Derma Sciences, Inc. | 12 | 2015-11-19 |
| Advanced Medical Solutions, Ltd. | 10 | 2023-10-26 |
346 more applicants have FRO clearances. See the full list in Caduvo.
Most recent FRO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254041 | Magic Science Supply, LLC | SkinSmart Antimicrobial HydroGel | 2026-09-11 | 269 |
| K261646 | Beijing Kreate Medical Co., Ltd. | Redermax® Antibacterial Wound Matrix | 2026-08-14 | 88 |
| K253665 | Urgo Medical North America, LLC | Vashe Plus Antimicrobial Solution | 2026-08-11 | 263 |
| K261023 | Sonoma Pharmaceuticals, Inc. | Microdacyn Wound Irrigation Solution | 2026-06-24 | 86 |
| K251929 | Silverceuticals, Inc. | SilverCeuticals® Antimicrobial Wound Gel | 2026-06-24 | 366 |
Recalls for FRO devices
82 product recalls in 45 recall events; 38 initiated in the last five years and 40 still open. Most recent: 2026-06-08.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 8 |
| 2021 | 6 |
| 2022 | 10 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 11 |
| 2026 | 7 |
Frequently asked questions
What is FDA product code FRO?
FRO is the FDA product code for dressing, wound, drug. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is FRO?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code FRO?
Across 708 cleared submissions the average was 187 days from receipt to decision (median 148).
Which companies have the most FRO clearances?
Huizhou Foryou Medical Devices Co., Ltd. (16); Convatec, A Division of E.R. Squibb & Sons (13); Winner Medical Co., Ltd. (12); Derma Sciences, Inc. (12); Advanced Medical Solutions, Ltd. (10).
Have FRO devices been recalled?
Yes: 82 product recalls across 45 recall events; the most recent began 2026-06-08.
Next steps
- Run an FDA pathway report with predicate devices for product code FRO
- Run a recall and safety report across every FRO manufacturer
- Watch product code FRO 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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