FDA product code FRG: Wrap, Sterilization
FRG is the FDA product code for wrap, sterilization. It is a Class II device, regulated under 21 CFR 880.6850 and reviewed by the General Hospital panel. FDA has cleared 323 510(k) submissions under FRG, 42 in the last five years, from 177 different applicants. The average 510(k) review took 140 days (median 90); 187 days on average over the last three years. FDA has posted 50 recalls for FRG devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Wrap, Sterilization |
| Device class | Class II |
| Regulation | 21 CFR 880.6850 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FRG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 227 |
| 2018 | 5 | 182 |
| 2019 | 9 | 230 |
| 2020 | 5 | 175 |
| 2021 | 4 | 172 |
| 2022 | 9 | 265 |
| 2023 | 9 | 192 |
| 2024 | 11 | 177 |
| 2025 | 9 | 185 |
| 2026 | 4 | 198 |
Compare with all 510(k) review times · Search every FRG clearance
Top FRG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardinal Health200, LLC | 11 | 2018-12-11 |
| Kimberly-Clark Corp. | 11 | 2014-11-10 |
| Medline Industries, Inc. | 9 | 2020-01-24 |
| Case Medical, Inc. | 9 | 2017-02-10 |
| Wipak OY | 7 | 2024-06-07 |
172 more applicants have FRG clearances. See the full list in Caduvo.
Most recent FRG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261897 | O&M Halyard, Inc. | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | 2026-07-02 | 27 |
| K252823 | Dukal, LLC | Dukal Crepe Paper Sterilization Wrap | 2026-05-28 | 266 |
| K253454 | O&M Halyard, Inc. | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | 2026-05-18 | 227 |
| K251347 | Sterivic Medical Co., Ltd. | Sterilization Pouch/Roll | 2026-01-28 | 273 |
| K251177 | Guangdong Maidi Medical Co., Ltd. | Self-Seal Sterilization Pouch and Roll | 2025-12-12 | 240 |
Recalls for FRG devices
50 product recalls in 8 recall events; 4 initiated in the last five years and 3 still open. Most recent: 2022-12-05.
| Year | Recalls |
|---|---|
| 2017 | 29 |
| 2020 | 14 |
| 2022 | 4 |
Frequently asked questions
What is FDA product code FRG?
FRG is the FDA product code for wrap, sterilization. It is a Class II device, regulated under 21 CFR 880.6850 and reviewed by the General Hospital panel.
What device class is FRG?
Class II, regulation 21 CFR 880.6850. Typical premarket route: 510(k).
How long does a 510(k) take for product code FRG?
Across 323 cleared submissions the average was 140 days from receipt to decision (median 90).
Which companies have the most FRG clearances?
Cardinal Health200, LLC (11); Kimberly-Clark Corp. (11); Medline Industries, Inc. (9); Case Medical, Inc. (9); Wipak OY (7).
Have FRG devices been recalled?
Yes: 50 product recalls across 8 recall events; the most recent began 2022-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code FRG
- Run a recall and safety report across every FRG manufacturer
- Watch product code FRG 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times