Atlas FDA

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

Australian Optical Co., Inc. — Predicate Candidate Screening

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

54 daysmedian FDA review time
320 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943562SUNGLASSESAustralian Optical Co., Inc.1994-09-14540
K943561SPECTACLE FRAMEAustralian Optical Co., Inc.1994-09-14540
K943640SUNGLASS CLIPAustralian Optical Co., Inc.1994-09-14490
K943641SPECTACLE FRAMEAustralian Optical Co., Inc.1994-09-14490
K935678SUNGLASS FRAMEAustralian Optical Co., Inc.1994-02-16820
K930331SPECTACLE FRAMEAustralian Optical Co., Inc.1993-12-083200
K911332SPECTACLE FRAMEAustralian Optical Co., Inc.1991-05-06410
K910179OPTICAL FRAMEAustralian Optical Co., Inc.1991-04-10850

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