Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Famidoc Technology Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
437 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212918 | Heat StimPlus | Famidoc Technology Co., Ltd. | 2021-12-13 | 90 | 0 |
| K130723 | FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TEN | Famidoc Technology Co., Ltd. | 2014-02-07 | 326 | 0 |
| K113010 | FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULA | Famidoc Technology Co., Ltd. | 2012-12-21 | 437 | 0 |
| K113761 | INFRARED THERMOMETER | Famidoc Technology Co., Ltd. | 2012-09-07 | 261 | 0 |
| K072641 | DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. | Famidoc Technology Co., Ltd. | 2007-11-01 | 44 | 0 |
| K052849 | INFRARED THERMOMETER, FDIR-V1 | Famidoc Technology Co., Ltd. | 2005-10-26 | 15 | 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