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

Galileo Electro-Optics Corp. — Predicate Candidate Screening

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

230 daysmedian FDA review time
379 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K981928GALILEO DISPOSABLE ENDOSCOPESGalileo Electro-Optics Corp.1998-08-06650
K962256GALILEO HYSTEROSCOPES AND LAPAROSCOPESGalileo Electro-Optics Corp.1996-12-061770
K962116GALILEO ENDOSCOPESGalileo Electro-Optics Corp.1996-11-271800
K934649GALILEO ENDOSCOPESGalileo Electro-Optics Corp.1994-10-133790
K934707GALILEO ARTHROSCOPESGalileo Electro-Optics Corp.1994-10-073720
K936280GALILEO ARTHROSCOPESGalileo Electro-Optics Corp.1994-07-122840
K936279GALILEO ENDOSCOPESGalileo Electro-Optics Corp.1994-05-162300

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