Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HMT — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
44 daysmedian FDA review time
87 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | Visitec Co. | 1995-02-14 | 83 | 0 |
| K905460 | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | Angiosystems, Inc. | 1991-02-06 | 63 | 0 |
| K872620 | SOLOS EYESITE DRAPES | Solos Ophthalmology | 1987-07-31 | 25 | 0 |
| K871706 | OPTHA PREP | Treace Medical, Inc. | 1987-05-18 | 17 | 0 |
| K854613 | SURGICAL DRAPES, OPHTHALMIN | Charles Atkins & Co. | 1986-02-13 | 87 | 0 |
| K831340 | DRAIN-R-DRAPE(EYE | Sur-Tech, Inc. | 1983-06-08 | 44 | 0 |
| K830822 | EYE DRAPE | CooperVision, Inc. | 1983-04-06 | 22 | 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