Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Summit Technology, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
180 daysmedian FDA review time
305 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980675 | SUMMIT KRUMEICH-BARRAQUER MICROKERATOME | Summit Technology, Inc. | 1998-12-22 | 305 | 1 |
| K926470 | LASER AND EMPHASIS SCLEROSTOMY TIP | Summit Technology, Inc. | 1993-07-22 | 206 | 0 |
| K915651 | OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM | Summit Technology, Inc. | 1992-06-15 | 180 | 0 |
| K912522 | OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER | Summit Technology, Inc. | 1991-07-25 | 64 | 0 |
| K904470 | SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE | Summit Technology, Inc. | 1990-12-24 | 84 | 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