Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GDL · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
62 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881394 | NON-STERILE SUTURE NEEDLES | China National Medicines C/O Havel'S | 1988-04-08 | 4 | 0 |
| K851781 | 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES | Artiberia | 1985-06-20 | 56 | 0 |
| K851782 | 25-450 TO 25-540 VARIOUS SUTURE FORCEPS | Artiberia | 1985-06-20 | 56 | 0 |
| K813589 | SHARTPOINT EYED NEEDLES | S. Jackson, Inc. | 1982-01-18 | 21 | 0 |
| K812566 | UNIVERSAL SUTURE PASSER | Ortho Pared Instruments, Inc. | 1981-11-10 | 62 | 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