FDA product code · General Hospital · Class 2
FLE: Sterilizer, Steam
FLE is FDA's product code for "Sterilizer, Steam": a Class 2 device classified under 21 CFR 880.6880, reviewed by the General Hospital panel.
510(k) review time for FLE
Across 46 510(k) clearances under FLE decided from 2018-01-01 to 2026-10-06, the median was 136 days from FDA receipt to decision. Half took between 100 and 227 days, and 80% were decided within 254 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 100 |
| Median | 136 |
| 75th percentile | 227 |
| 80th percentile | 254 |
| 90th percentile | 308 |
| Slowest | 463 |
| Year | Median days | n |
|---|---|---|
| 2018 | 146 | 8 |
| 2019 | 192 | 5 |
| 2021 | 147 | 5 |
| 2022 | 133 | 10 |
| 2023 | 88 | 7 |
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.
FLE in the public FDA record
| 510(k) clearances, all years | 185 |
|---|---|
| Device recalls | 18 |
| Establishment listings | 180 |
| GUDID device identifiers | 1,331 |
Counts of records, not of devices or events. Adverse event reports for FLE 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 FLE
7 FDA recognized consensus standards cite FLE, 1 of them recognized only in part, among them ANSI AAMI ST8:2013/(R)2018; AAMI ANSI ST55:2016/(R)2023; AAMI TIR17:2017/(R)2020. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 14-406 ANSI AAMI ST8:2013/(R)2018 — Hospital steam sterilizers
- 14-518 AAMI ANSI ST55:2016/(R)2023 — Table-top steam sterilizers
- 14-588 AAMI TIR17:2017/(R)2020 — Compatibility of materials subjected to sterilization
- 14-597 AAMI ANSI ST108:2023 — Water for the processing of medical devices
- 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
- 14-609 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.