Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HPQ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
107 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952289 | WELCH ALLYN FIBER OPTIC HEADLIGNT | Welch Allyn, Inc. | 1995-07-14 | 59 | 0 |
| K951337 | FIBER HEAD LIGHT FH-300 | Neitz Instruments Company, Ltd. | 1995-06-08 | 76 | 0 |
| K861747 | KEELER FIBEROPTIC HEADLAMP | Keeler Instruments, Inc. | 1986-08-21 | 107 | 0 |
| K861746 | KEELER DUAL LIGHTSOURCE | Keeler Instruments, Inc. | 1986-08-21 | 107 | 0 |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | Kelleher Corp. | 1982-11-10 | 104 | 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