Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAB — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
208 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012199 | DIGICAP | Humana USA, Inc. | 2001-12-19 | 159 | 0 |
| K980988 | AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(A | Axya Medical, Inc. | 1998-05-11 | 55 | 0 |
| K932591 | ENDO-JUDGE | Synergistic Medical Technologies, Inc. | 1993-12-22 | 208 | 0 |
| K895681 | CONTRAST BACKGROUND MATERIAL | Applied Medical Technologies | 1989-10-24 | 33 | 0 |
| K863595 | COATED SUTURE NEEDLE | Sharpoint, Inc. | 1986-10-24 | 39 | 0 |
| K831648 | ANCHOR BRAND SURGICAL NEEDLES | Anchor Products Co. | 1983-08-16 | 85 | 0 |
| K812444 | RADIATION STERILIZATION FOR NEEDLE CNTR | Devon Industries, Inc. | 1981-12-14 | 108 | 0 |
| K801976 | SCANLAN STERNUM NEEDLE-SUTURE | Scanlan Intl., Inc. | 1980-09-26 | 38 | 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