Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
179 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Th | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-03-06 | 86 | 0 |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-01-24 | 66 | 0 |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Po | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 | 83 | 0 |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser Syst | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 | 83 | 0 |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fibe | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-20 | 62 | 0 |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 | 179 | 0 |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 | 175 | 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