Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Arc Medical Supplies (Beijing) Co, Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
71 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022666 | PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE | Arc Medical Supplies (Beijing) Co, Ltd. | 2002-10-09 | 61 | 0 |
| K022664 | PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. | Arc Medical Supplies (Beijing) Co, Ltd. | 2002-09-10 | 32 | 0 |
| K000541 | SILK NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 | 71 | 0 |
| K000542 | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 | 71 | 0 |
| K000537 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 | 70 | 0 |
| K000539 | NYLON NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 | 70 | 0 |
| K000540 | POLYESTER NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 | 70 | 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