Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HPL — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
509 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931731 | STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY | Storz Instrument Co. | 1994-08-29 | 509 | 0 |
| K933739 | 360 DEGREE FIXATION LIGHT | Varitronics | 1994-03-14 | 223 | 0 |
| K873914 | ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) | Richmond Products, Inc. | 1987-12-11 | 77 | 0 |
| K854383 | KERATOLUX | Carl Zeiss, Inc. | 1985-11-12 | 13 | 0 |
| K801381 | FITE FIXATION TOY FOR OCULAR EXAM | Fite Engineering Corp. | 1980-07-28 | 47 | 0 |
| K800112 | AMBLYOPIA TRAINER | Life-Tech Instruments, Inc. | 1980-03-10 | 54 | 0 |
| K781313 | VISION-STIMULATOR, CAM | Clement Clarke, Inc. | 1979-01-26 | 179 | 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