Class Class II
Ultra-Fast Vitri; Ultra-Fast Warm (K251305)
Description
Ultra-Fast Vitri; Ultra-Fast Warm by Kitazato Corporation, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251305
Clearance Date2025-08-26
Clearance TypeTraditional
Product CodeMQL
Regulation Number884.6180
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251305
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ultra-Fast Vitri; Ultra-Fast Warm (K251305) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171748 | Vitrification Kit and Thawing Kit | Kitazato Corporation | 2017 |
Trace the full predicate network for K251305
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.