Product code FLL: 510(k) clearances and predicates
Product code FLL covers Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG). FDA lists 798 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
798 clearances on file under product code FLL. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 24 |
| 2023 | 17 |
| 2024 | 13 |
| 2025 | 6 |
| 2026 so far | 2 |
Recent clearances
Newest FLL clearances in the FDA index, with applicant and decision date:
- K253162, Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG), applicant Unimed Medical Supplies, Inc., decided 2026-06-05. FDA record
- K251160, Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS), applicant Shenzhen Med-Link Electronics Tech Co., Ltd., decided 2026-01-08. FDA record
- K250470, Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103), applicant Shenzhen AOJ Medical Technology Co., Ltd., decided 2025-06-23. FDA record
- K243000, Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106), applicant Shenzhen Medke Technology Co., Ltd., decided 2025-06-20. FDA record
- K250878, YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107), applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., decided 2025-05-22. FDA record
- K243082, Infrared Thermometer, applicant Guangzhou Daxin Health Technology Co., Ltd., decided 2025-04-25. FDA record
- K250401, AION TempShield, applicant Aion Biosystems, Inc., decided 2025-03-14. FDA record
- K243136, Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209), applicant Shenzhen Finicare Co., Ltd., decided 2025-02-14. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS), Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103). Watch new FLL clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code FLL?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FLL clearances include Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG).
How many 510(k) clearances use product code FLL?
798 at the time this page was generated, from openFDA records.
How do I find a predicate device under FLL?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new FLL clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.