Ultra-Fast Warm— 510(k) K260248
Substantially EquivalentKitazato Corporation
FDA 510(k) clearance K260248 for Ultra-Fast Warm, Substantially Equivalent on 2026-04-28. Applicant: Kitazato Corporation. Device class: 2.
Summary
Kitazato Corporation's Ultra-Fast Warm is filed under product code MQL (Media, Reproductive). The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 884.6180. Obstetrics/Gynecology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Kitazato filed from Fuji, Japan. The record shows 91 calendar days from receipt to decision (January 27 to April 28, 2026).
Clearance details
- Applicant
- Kitazato Corporation
- Product code
- Product code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fuji, JP
Recent devices under product code MQL
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view all- K200249 — Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
- K193522 — iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
- K192845 — Sperm Freeze, Sperm Fridge
- K192540 — Kitazato ET Catheters
- K190199 — SepaSperm Washing Solution, SepaSperm Solution
Data sourced from openFDA. This site is unofficial and independent of the FDA.