Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HIC — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
787 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955790 | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY | Trylon Corp. | 1996-03-21 | 90 | 0 |
| K923656 | LIGHTING SOURCE SYSTEM | Galenica Enterprises, Inc. | 1994-09-08 | 787 | 0 |
| K902516 | NEW LENGTH SUGITA APPLIERS | Sims Surgical, Inc. | 1990-07-03 | 26 | 0 |
| K897100 | CENTURION VAGINAL SPECULUM | Tri-State Hospital Supply Corp. | 1990-03-16 | 85 | 0 |
| K853257 | SPECULITE DISPOSABLE VAGINAL LIGHT | Trylon Associates, Ltd. | 1985-12-27 | 147 | 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