Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HKL · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
149 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001111 | PANORET, MODEL 1000A | Cmt Medical Technologies, Ltd. | 2000-07-07 | 92 | 0 |
| K950789 | STREAK RETINOSCOPE RX-1 | Neitz Instruments Company, Ltd. | 1995-03-28 | 35 | 0 |
| K950790 | STREAK RETINOSCOPE RX-2 | Neitz Instruments Company, Ltd. | 1995-03-22 | 29 | 0 |
| K893171 | VISTA STREAK RETINOSCOPE (AC-POWERED) | Keeler Instruments, Inc. | 1989-09-21 | 149 | 0 |
| K812764 | KOI BLUE FIELD ENTOPTOSCOPE | Koi, Inc. | 1981-12-02 | 61 | 0 |
| K800238 | MOIRE FRINGE VISOMETER AFTER LOTMAR | Hagg-Streit Service, Inc. | 1980-03-10 | 34 | 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