Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HPN · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905237 | EYE SEE INSTRUMENT | King Tool, Inc. | 1991-02-14 | 90 | 0 |
| K896473 | H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR | Emory University School of Medicine | 1990-02-09 | 88 | 0 |
| K880855 | PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG | Richard James, Inc. | 1988-04-01 | 31 | 0 |
| K860960 | RARE EARTH INTRA-OCULAR MAGNET | Ameritek, Inc. | 1986-03-31 | 18 | 0 |
| K831702 | RARE-EARTH INTRA-OCULAR MAGNET | Miami Eye Technology, Inc. | 1983-06-30 | 36 | 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