Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Rio Flexon Technology Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100226 | WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM- | Rio Flexon Technology Co., Ltd. | 2010-03-18 | 52 | 0 |
| K081256 | WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, | Rio Flexon Technology Co., Ltd. | 2008-05-27 | 25 | 0 |
| K062445 | MONITORING EAR THERMOMETER, MODEL BTM-D1A | Rio Flexon Technology Co., Ltd. | 2007-02-16 | 178 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda