Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GCZ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
77 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904536 | JAIN GRAFT ASSIST | Jain Surgical Equipment, Inc. | 1990-11-29 | 56 | 0 |
| K893870 | ADAMS BREAST IMPLANT PROTECTOR | Adept-Med Intl., Inc. | 1989-07-14 | 49 | 0 |
| K870809 | MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 | Adept-Med Intl., Inc. | 1987-03-19 | 16 | 1 |
| K802806 | VISECERA RETAINER | Adept-Med Intl., Inc. | 1981-01-23 | 77 | 1 |
| K801610 | CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR | Edward Weck, Inc. | 1980-08-04 | 20 | 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