FDA product code · General Hospital · Class 2
FRC: Indicator, Biological Sterilization Process
FRC is FDA's product code for "Indicator, Biological Sterilization Process": a Class 2 device classified under 21 CFR 880.2800, reviewed by the General Hospital panel.
510(k) review time for FRC
Across 64 510(k) clearances under FRC decided from 2018-01-01 to 2026-10-06, the median was 102 days from FDA receipt to decision. Half took between 76 and 157 days, and 80% were decided within 181 days. These are past clearances, not a forecast for a new submission.
| Fastest | 12 |
|---|---|
| 25th percentile | 76 |
| Median | 102 |
| 75th percentile | 157 |
| 80th percentile | 181 |
| 90th percentile | 253 |
| Slowest | 495 |
| Year | Median days | n |
|---|---|---|
| 2018 | 97 | 18 |
| 2019 | 88 | 5 |
| 2020 | 150 | 10 |
| 2021 | 107 | 5 |
| 2022 | 193 | 5 |
| 2023 | 190 | 6 |
| 2024 | 105 | 8 |
| 2025 | 29 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FRC in the public FDA record
| 510(k) clearances, all years | 206 |
|---|---|
| Device recalls | 40 |
| Establishment listings | 229 |
| GUDID device identifiers | 499 |
Counts of records, not of devices or events. Adverse event reports for FRC are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite FRC
6 FDA recognized consensus standards cite FRC, among them ISO 14161 Second edition 2009-09-15; USP-NF M98795_02_01; USP-NF M7414_01_01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 14-336 ISO 14161 Second edition 2009-09-15 — Sterilization of health care products - Biological indicators - Guidance for the selection use and interpretation of results
- 14-566 USP-NF M98795_02_01 — <55> Biological Indicators -- Resistance Performance Tests
- 14-567 USP-NF M7414_01_01 — <1229.5> Biological Indicators for Sterilization
- 14-571 ISO 11138-8 First edition 2021-07 — Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
- 14-601 ISO 17665 First edition 2024-03 — Sterilization of health care products - Moist heat - Requirements for the development validation and routine control of a sterilization process for medical devices
- 14-610 ISO 11138-7 First edition 2019-03 — Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection use and interpretation of results
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.