Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Foshan Pingchuang 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) |
|---|---|---|---|---|---|
| K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Foshan Pingchuang Medical Technology Co., Ltd. | 2026-06-17 | 261 | 0 |
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, | Foshan Pingchuang Medical Technology Co., Ltd. | 2025-12-15 | 91 | 0 |
| K212104 | Water-soluble Personal Lubricant | Foshan Pingchuang Medical Technology Co., Ltd. | 2021-11-18 | 135 | 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