FDA product code · General Hospital · Class 2
FLL: Continuous Measurement Thermometer
FLL is FDA's product code for "Continuous Measurement Thermometer": a Class 2 device classified under 21 CFR 880.2910, reviewed by the General Hospital panel.
510(k) review time for FLL
Across 183 510(k) clearances under FLL decided from 2018-01-01 to 2026-10-06, the median was 211 days from FDA receipt to decision. Half took between 153 and 293 days, and 80% were decided within 313 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 153 |
| Median | 211 |
| 75th percentile | 293 |
| 80th percentile | 313 |
| 90th percentile | 388 |
| Slowest | 821 |
| Year | Median days | n |
|---|---|---|
| 2018 | 209 | 35 |
| 2019 | 198 | 22 |
| 2020 | 194 | 21 |
| 2021 | 218 | 43 |
| 2022 | 218 | 24 |
| 2023 | 295 | 17 |
| 2024 | 223 | 13 |
| 2025 | 131 | 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.
FLL in the public FDA record
| 510(k) clearances, all years | 798 |
|---|---|
| Device recalls | 18 |
| Establishment listings | 1,330 |
| GUDID device identifiers | 4,367 |
Counts of records, not of devices or events. Adverse event reports for FLL 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 FLL
7 FDA recognized consensus standards cite FLL, among them IEEE Std 11073-10408-2019; ASTM E1104-98 (Reapproved 2023); ASTM E1965-98 (Reapproved 2023). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 13-132 IEEE Std 11073-10408-2019 — Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
- 6-124 ASTM E1104-98 (Reapproved 2023) — Standard Specification for Clinical Thermometer Probe Covers and Sheaths
- 6-125 ASTM E1965-98 (Reapproved 2023) — Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- 6-177 ASTM E1112-00 (Reapproved 2018) — Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- 6-405 IEC 80601-2-59 Edition 2.0 2017-09 — Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
- 6-421 ISO 80601-2-56 Second edition 2017-03 [Including AMD1:2018] — Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
- 6-508 IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION — Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.