FDA product code FLL: Continuous Measurement Thermometer
FLL is the FDA product code for continuous measurement thermometer. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel. FDA has cleared 798 510(k) submissions under FLL, 62 in the last five years, from 425 different applicants. The average 510(k) review took 139 days (median 108); 200 days on average over the last three years. FDA has posted 19 recalls for FLL devices, 3 initiated in the last five years.
Definition
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
Classification
| Field | Value |
|---|---|
| Device name | Continuous Measurement Thermometer |
| Device class | Class II |
| Regulation | 21 CFR 880.2910 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FLL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 16 | 204 |
| 2018 | 35 | 237 |
| 2019 | 22 | 210 |
| 2020 | 21 | 212 |
| 2021 | 43 | 234 |
| 2022 | 24 | 268 |
| 2023 | 17 | 313 |
| 2024 | 13 | 203 |
| 2025 | 6 | 138 |
| 2026 | 2 | 260 |
Compare with all 510(k) review times · Search every FLL clearance
Top FLL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microlife Intellectual Property GmbH | 20 | 2022-03-01 |
| R & D Batteries, Inc. | 19 | 1995-08-18 |
| Taidoc Technology Corporation | 16 | 2022-04-05 |
| Radiant Innovation, Inc. | 15 | 2024-06-05 |
| K-Jump Health Co., Ltd. | 14 | 2018-09-24 |
420 more applicants have FLL clearances. See the full list in Caduvo.
Most recent FLL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253162 | Unimed Medical Supplies, Inc. | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | 2026-06-05 | 252 |
| K251160 | Shenzhen Med-Link Electronics Tech Co., Ltd. | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | 2026-01-08 | 268 |
| K250470 | Shenzhen AOJ Medical Technology Co., Ltd. | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | 2025-06-23 | 125 |
| K243000 | Shenzhen Medke Technology Co., Ltd. | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | 2025-06-20 | 267 |
| K250878 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | 2025-05-22 | 59 |
Recalls for FLL devices
19 product recalls in 14 recall events; 3 initiated in the last five years and 5 still open. Most recent: 2026-08-20.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 5 |
| 2021 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FLL?
FLL is the FDA product code for continuous measurement thermometer. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel.
What device class is FLL?
Class II, regulation 21 CFR 880.2910. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLL?
Across 798 cleared submissions the average was 139 days from receipt to decision (median 108).
Which companies have the most FLL clearances?
Microlife Intellectual Property GmbH (20); R & D Batteries, Inc. (19); Taidoc Technology Corporation (16); Radiant Innovation, Inc. (15); K-Jump Health Co., Ltd. (14).
Have FLL devices been recalled?
Yes: 19 product recalls across 14 recall events; the most recent began 2026-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code FLL
- Run a recall and safety report across every FLL manufacturer
- Watch product code FLL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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