Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro-Energy Medical 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) |
|---|---|---|---|---|---|
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40- | Micro-Energy Medical Technology Co., Ltd. | 2026-06-18 | 27 | 0 |
| K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R | Micro-Energy Medical Technology Co., Ltd. | 2025-12-12 | 105 | 0 |
| K251049 | SurgiLight 1470 Diode Laser System (Model:Halo) | Micro-Energy Medical Technology Co., Ltd. | 2025-07-02 | 90 | 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