Atlas FDA

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

Kitazato Corporation — Predicate Candidate Screening

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

228 daysmedian FDA review time
272 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260248Ultra-Fast WarmKitazato Corporation2026-04-28910
K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation2025-08-261200
K200249Sequential Culture Media (Fertilization Medium [without HSA/Kitazato Corporation2020-10-232630
K193522iMedium Single Step; iMedium Single Step with HSA; iMedium SKitazato Corporation2020-08-252500
K192845Sperm Freeze, Sperm FridgeKitazato Corporation2020-08-173190
K192540Kitazato ET CathetersKitazato Corporation2020-05-012280
K190199SepaSperm Washing Solution, SepaSperm SolutionKitazato Corporation2019-09-262340
K181469Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation2018-11-091580
K182002Cumulus RemoverKitazato Corporation2018-10-23890
K171748Vitrification Kit and Thawing KitKitazato Corporation2017-12-141840
K162878Kitazato ET CathetersKitazato Corporation2017-07-132720
K162881Kitazato OPU NeedlesKitazato Corporation2017-07-112700
K162667Kitazato IUI CatheterKitazato Corporation2017-05-112270

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