FDA product code FRC: Indicator, Biological Sterilization Process
FRC is the FDA product code for indicator, biological sterilization process. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel. FDA has cleared 206 510(k) submissions under FRC, 26 in the last five years, from 56 different applicants. The average 510(k) review took 169 days (median 116); 74 days on average over the last three years. FDA has posted 40 recalls for FRC devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Indicator, Biological Sterilization Process |
| Device class | Class II |
| Regulation | 21 CFR 880.2800 |
| 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 FRC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 10 | 154 |
| 2018 | 18 | 107 |
| 2019 | 5 | 81 |
| 2020 | 10 | 181 |
| 2021 | 5 | 101 |
| 2022 | 5 | 190 |
| 2023 | 6 | 162 |
| 2024 | 8 | 142 |
| 2025 | 6 | 51 |
| 2026 | 1 | 30 |
Compare with all 510(k) review times · Search every FRC clearance
Top FRC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 33 | 2026-04-08 |
| 3M Company | 31 | 2025-01-28 |
| Advanced Sterilization Products | 17 | 2015-10-29 |
| Raven Biological Laboratories, Inc. | 12 | 2009-10-21 |
| Spsmedical Supply Corp. | 9 | 2013-11-26 |
51 more applicants have FRC clearances. See the full list in Caduvo.
Most recent FRC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260766 | STERIS Corporation | Celerity 5 HP Biological Indicator (LCB052) | 2026-04-08 | 30 |
| K252680 | STERIS Corporation | Celerity 20 HP Biological Indicator | 2025-09-24 | 30 |
| K251122 | Terragene | Terragene® Bionova® BT20 Biological Indicator | 2025-08-04 | 115 |
| K251452 | Steris | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | 2025-06-06 | 28 |
| K250061 | STERIS Corporation | Celerity Incubator | 2025-02-06 | 27 |
Recalls for FRC devices
40 product recalls in 24 recall events; 15 initiated in the last five years and 15 still open. Most recent: 2026-04-13.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2022 | 6 |
| 2023 | 5 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code FRC?
FRC is the FDA product code for indicator, biological sterilization process. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel.
What device class is FRC?
Class II, regulation 21 CFR 880.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code FRC?
Across 206 cleared submissions the average was 169 days from receipt to decision (median 116).
Which companies have the most FRC clearances?
STERIS Corporation (33); 3M Company (31); Advanced Sterilization Products (17); Raven Biological Laboratories, Inc. (12); Spsmedical Supply Corp. (9).
Have FRC devices been recalled?
Yes: 40 product recalls across 24 recall events; the most recent began 2026-04-13.
Next steps
- Run an FDA pathway report with predicate devices for product code FRC
- Run a recall and safety report across every FRC manufacturer
- Watch product code FRC 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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