Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pilkington Barnes-Hind, Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961299 | PRECISION UV (VASURFILCON A) | Pilkington Barnes-Hind, Ltd. | 1996-10-01 | 180 | 0 |
| K952261 | HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT M | Pilkington Barnes-Hind, Ltd. | 1995-07-05 | 51 | 0 |
| K946012 | PRECISION UV(TM) (VASURFICON A) | Pilkington Barnes-Hind, Ltd. | 1995-01-24 | 43 | 0 |
| K944722 | PRECISION UV(TM) (VASURFILCON A) | Pilkington Barnes-Hind, Ltd. | 1994-10-03 | 4 | 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