Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Foosin Medical Supplies Inc., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
302 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201139 | WEGO-PDO Barbed Suture | Foosin Medical Supplies Inc., Ltd. | 2020-10-20 | 175 | 0 |
| K193209 | Wego-Stainless Steel | Foosin Medical Supplies Inc., Ltd. | 2020-02-19 | 90 | 0 |
| K183001 | WEGO-PGLA RAPID | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 | 90 | 0 |
| K183004 | WEGO-PGA RAPID | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 | 90 | 0 |
| K170842 | WEGO-PTFE | Foosin Medical Supplies Inc., Ltd. | 2017-07-31 | 132 | 0 |
| K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | Foosin Medical Supplies Inc., Ltd. | 2014-11-14 | 46 | 0 |
| K130735 | SYNTHETIC ABSORBABLE SUTURE | Foosin Medical Supplies Inc., Ltd. | 2014-01-14 | 302 | 0 |
| K130737 | SYNTHETIC ABSORBABLE SUTURE | Foosin Medical Supplies Inc., Ltd. | 2014-01-14 | 302 | 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