FDA product code · General Hospital · Class 2
MLR: Sterilizer, Chemical
MLR is FDA's product code for "Sterilizer, Chemical": a Class 2 device classified under 21 CFR 880.6860, reviewed by the General Hospital panel.
510(k) review time for MLR
Across 20 510(k) clearances under MLR decided from 2018-01-01 to 2026-10-06, the median was 129 days from FDA receipt to decision. Half took between 69 and 220 days, and 80% were decided within 228 days. These are past clearances, not a forecast for a new submission.
| Fastest | 24 |
|---|---|
| 25th percentile | 69 |
| Median | 129 |
| 75th percentile | 220 |
| 80th percentile | 228 |
| 90th percentile | 279 |
| Slowest | 448 |
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.
MLR in the public FDA record
| 510(k) clearances, all years | 47 |
|---|---|
| Device recalls | 46 |
| Establishment listings | 123 |
| GUDID device identifiers | 665 |
Counts of records, not of devices or events. Adverse event reports for MLR 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 MLR
3 FDA recognized consensus standards cite MLR, 1 of them recognized only in part, among them AAMI TIR17:2017/(R)2020; AAMI TIR17:2024; IEC 61326-1 Edition 3.0 2020-10. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 14-588 AAMI TIR17:2017/(R)2020 — Compatibility of materials subjected to sterilization
- 14-609 AAMI TIR17:2024 — Compatibility of materials subjected to sterilization
- 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.