FDA product code · General Hospital · Class 2
FRA: Purifier, Air, Ultraviolet, Medical
FRA is FDA's product code for "Purifier, Air, Ultraviolet, Medical": a Class 2 device classified under 21 CFR 880.6500, reviewed by the General Hospital panel.
510(k) review time for FRA
Across 18 510(k) clearances under FRA decided from 2018-01-01 to 2026-10-06, the median was 177 days from FDA receipt to decision. Half took between 89 and 257 days, and 80% were decided within 265 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 89 |
| Median | 177 |
| 75th percentile | 257 |
| 80th percentile | 265 |
| 90th percentile | 271 |
| Slowest | 383 |
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.
FRA in the public FDA record
| 510(k) clearances, all years | 36 |
|---|
Counts of records, not of devices or events. Adverse event reports for FRA 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 FRA
1 FDA recognized consensus standard cite FRA, 1 of them recognized only in part, among them IEC 61326-1 Edition 3.0 2020-10. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 19-42 IEC 61326-1 Edition 3.0 2020-10 (partial recognition) — Electrical equipment for measurement control and laboratory use - EMC requirements - Part 1: General requirements
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.