Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HCF — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
75 daysmedian FDA review time
130 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150882 | Edwards Suture Fastening System | Edwards Lifesciences, LLC | 2015-06-16 | 75 | 0 |
| K931379 | MICROVASIVE INSURG LAPTIE SUTURE LIGATOR | Boston Scientific Corp | 1993-07-13 | 117 | 0 |
| K851452 | VALTRAC PURSESTING DEVICE | Davis & Geck, Inc. | 1985-06-12 | 62 | 0 |
| K841617 | STROVER HOOK | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K790577 | HEMORRHOIDAL LIGATOR | J. Sklar Mfg. Co., Inc. | 1979-04-23 | 26 | 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