Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Barnes-Hind, Inc. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

34 daysmedian FDA review time
91 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K852386SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNITBarnes-Hind, Inc.1985-09-04910
K812135BARNES-HIND WEEKLY CLEANERBarnes-Hind, Inc.1981-08-31340
K811554BARNES-HIND SPECTACLE LENS CLEANERBarnes-Hind, Inc.1981-07-02300
K810285BARNES-HIND ROSE BENGAL OPHTHALMIC STR.Barnes-Hind, Inc.1981-04-17740
K800582BARNES-HOND HARD CONTACT LENS STOR. CASEBarnes-Hind, Inc.1980-03-25110
K791901BARNES-HIND WETTING & SOAKING SOLUTIONBarnes-Hind, Inc.1979-11-16520
K781007AUTO-CONBarnes-Hind, Inc.1978-06-30110

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