Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hebei JT Medical 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) |
|---|---|---|---|---|---|
| K250722 | Nd: YAG Laser Therapy System (QN-1) | Hebei JT Medical Co., Ltd. | 2025-06-06 | 88 | 0 |
| K240658 | 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. | 2024-05-13 | 66 | 0 |
| K232181 | Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS | Hebei JT Medical Co., Ltd. | 2024-04-24 | 275 | 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