Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HPG · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
114 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910601 | PATHFINDER | Nurion Industries | 1991-05-14 | 90 | 0 |
| K910124 | LOW VISION ENHANCEMENT SYSTEM (LVES) | Triangle Investments | 1991-04-10 | 89 | 0 |
| K903558 | LASER CANE | Nurion Industries | 1990-09-27 | 50 | 0 |
| K902187 | POLARON | Nurion Industries | 1990-08-08 | 86 | 0 |
| K862338 | SENSORY 6 | Brytech, Inc. | 1986-09-03 | 75 | 0 |
| K823385 | ALES | Oms | 1983-03-09 | 114 | 0 |
| K761215 | F4912 NIGHT VISION AID | Itt Corp. | 1976-12-16 | 9 | 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