Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HGE · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
439 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951148 | OBSTI-HOOK | Onli | 1995-06-09 | 88 | 0 |
| K926425 | AMNIPERF(TM) | Raymart Development Co. | 1994-03-07 | 439 | 0 |
| K910518 | GLOVE-N-GEL AMNIOTOMY KIT | Epcom Medical Systems, Inc. | 1991-05-09 | 92 | 0 |
| K871087 | S.C.M.T. PERFORATOR | Salt Creek Medical Technologies | 1987-03-23 | 5 | 0 |
| K850758 | AMNIGLOVE & AMNICOT | Go Medical Industries Pty. , Ltd. | 1985-04-15 | 49 | 0 |
| K834177 | H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 | Imm Enterprises , Ltd. | 1983-12-27 | 36 | 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