Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trylon Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
471 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033033 | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. | 2004-11-22 | 423 | 0 |
| K011488 | SPIRABRUSH CX BIOPSY INSTRUMENT | Trylon Corp. | 2002-02-22 | 283 | 0 |
| K012070 | ORALLITE COMPREHENSIVE EXAM TRAY | Trylon Corp. | 2001-11-27 | 148 | 0 |
| K003995 | SPECULITE/ORALLITE | Trylon Corp. | 2001-03-16 | 80 | 0 |
| K963391 | SPECULITE | Trylon Corp. | 1997-12-12 | 471 | 1 |
| K955790 | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY | Trylon Corp. | 1996-03-21 | 90 | 0 |
| K953364 | SPECULITE | Trylon Corp. | 1995-12-08 | 144 | 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