Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Trek Medical Products, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
218 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920937 | COMPUTERIZED PUPIL | Trek Medical Products, Inc. | 1992-10-02 | 218 | 0 |
| K920944 | FTS-200 GAS SYSTEM | Trek Medical Products, Inc. | 1992-05-29 | 88 | 0 |
| K900808 | RAPID AUTOMATIC PNEUMOPERITONEUM-I | Trek Medical Products, Inc. | 1990-09-19 | 210 | 0 |
| K902784 | FIBER OPTIC LIGHT SOURCE | Trek Medical Products, Inc. | 1990-09-12 | 78 | 0 |
| K895813 | GLAUCOMA MECHANICAL TREPHINE | Trek Medical Products, Inc. | 1990-04-30 | 210 | 0 |
| K882403 | OPHTHALMIC FLUID INJECTOR | Trek Medical Products, Inc. | 1988-09-09 | 91 | 0 |
| K875195 | OPHTHALMIC LIGHT PIPE PICK | Trek Medical Products, Inc. | 1988-03-07 | 81 | 0 |
| K864035 | VES-10 INTRAOCULAR SCISSORS DRIVE | Trek Medical Products, Inc. | 1986-12-15 | 60 | 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