FDA applicant
Olympus Corp.
FDA records 149 decisions for Olympus Corp. (Lake Success, NY) from 1978 to 2007: 149 510(k) clearances. Most are in product codes CGX (Alkaline Picrate, Colorimetry, Creatinine) and CHJ (Mercuric Thiocyanate, Colorimetry, Chloride). Its devices cite 9 predicates, 0 of them its own earlier devices. 55 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Olympus Corporation”, “Olympus”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Olympus Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2026 so far, outlined.
Recalls per year
19in 2025
Class I Class II/III not classified
Planning a device like Olympus Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Olympus”
FDA records each applicant name separately; these may or may not be the same firm.