Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HIT — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
60 daysmedian FDA review time
351 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903001 | SLIMCATH (TM) | Gynopharma, Inc. | 1991-06-25 | 351 | 0 |
| K875026 | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | Lkc Technologies, Inc. | 1988-02-05 | 60 | 0 |
| K873908 | H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. | Richmond Products, Inc. | 1987-12-23 | 89 | 0 |
| K873911 | PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 | Richmond Products, Inc. | 1987-12-02 | 68 | 0 |
| K844694 | TITMUS VISION TESTER II | Titmus Optical, Inc. | 1985-01-22 | 50 | 0 |
| K844365 | COLOR VISION TESTERS | Luneau Laboratories | 1985-01-02 | 50 | 0 |
| K832843 | OSCAR COLOUR VISION TESTER | Keeler Instruments, Inc. | 1984-01-04 | 135 | 0 |
| K831074 | OSCAR COLOR VISION TESTER | Carl Zeiss, Inc. | 1983-04-28 | 24 | 0 |
| K810700 | CHROMOPS FM-100 COLOR VISION TESTER | Visidyne Corp. | 1981-04-10 | 25 | 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