Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zhejiang Longterm Medical Technology Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large | Zhejiang Longterm Medical Technology Co., Ltd. | 2022-05-31 | 375 | 0 |
| K202823 | Innomed NPWT Silicone Foam Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2021-12-15 | 447 | 0 |
| K192478 | LT Antibacterial Alginate with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2020-06-17 | 281 | 0 |
| K182458 | Longterm NPWT Foam Dressing Kit | Zhejiang Longterm Medical Technology Co., Ltd. | 2019-05-23 | 255 | 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