Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KGY · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
183 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933085 | GOODMAN BANDAGE | Megadyne Medical Products, Inc. | 1993-12-23 | 183 | 0 |
| K913678 | TROCAR CATHETER | Medovations, Inc. | 1991-12-16 | 119 | 0 |
| K910914 | SURGICAL TISSUE POUCH | Cook Urological, Inc. | 1991-03-28 | 23 | 1 |
| K832318 | ISOLATION BAG 3M | 3M Company | 1983-10-31 | 108 | 0 |
| K801823 | BAND-AID BRAND TRICOT MESH BANDAGES | Johnson & Johnson Professionals, Inc. | 1980-08-20 | 20 | 0 |
| K801824 | BAND-AID BRAND FLEXIBLE FABRIC BANDAGE | Johnson & Johnson Professionals, Inc. | 1980-08-20 | 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