FDA product code · General Hospital · Class 2
FRG: Wrap, Sterilization
FRG is FDA's product code for "Wrap, Sterilization": a Class 2 device classified under 21 CFR 880.6850, reviewed by the General Hospital panel.
510(k) review time for FRG
Across 65 510(k) clearances under FRG decided from 2018-01-01 to 2026-10-06, the median was 222 days from FDA receipt to decision. Half took between 90 and 266 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 90 |
| Median | 222 |
| 75th percentile | 266 |
| 80th percentile | 269 |
| 90th percentile | 300 |
| Slowest | 1,192 |
| Year | Median days | n |
|---|---|---|
| 2018 | 150 | 5 |
| 2019 | 258 | 9 |
| 2020 | 122 | 5 |
| 2022 | 217 | 9 |
| 2023 | 230 | 9 |
| 2024 | 182 | 11 |
| 2025 | 151 | 9 |
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.
FRG in the public FDA record
| 510(k) clearances, all years | 323 |
|---|---|
| Device recalls | 50 |
| Establishment listings | 492 |
| GUDID device identifiers | 4,462 |
Counts of records, not of devices or events. Adverse event reports for FRG 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 FRG
1 FDA recognized consensus standard cite FRG, among them ISO 17665 First edition 2024-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 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
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.