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510(k) K251305

Ultra-Fast Vitri; Ultra-Fast Warm by Kitazato Corporation — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2025
Date Received
April 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

Other clearances by Kitazato Corporation

  • K200249 — Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with (October 23, 2020)
  • K193522 — iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA (August 25, 2020)
  • K192845 — Sperm Freeze, Sperm Fridge (August 17, 2020)
  • K192540 — Kitazato ET Catheters (May 1, 2020)
  • K190199 — SepaSperm Washing Solution, SepaSperm Solution (September 26, 2019)
  • K181469 — Cryotop®US-flash and Cryotop®US-scoop (November 9, 2018)
  • K182002 — Cumulus Remover (October 23, 2018)
  • K171748 — Vitrification Kit and Thawing Kit (December 14, 2017)
  • K162878 — Kitazato ET Catheters (July 13, 2017)
  • K162881 — Kitazato OPU Needles (July 11, 2017)

Other clearances for product code MQL

  • K252672 — CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (February 20, 2026)
  • K250445 — Fast Warm - NX (September 12, 2025)
  • K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin (August 27, 2025)
  • K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentami (May 30, 2025)
  • K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (April 10, 2025)
  • K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (April 10, 2025)
  • K242107 — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); (March 21, 2025)
  • K241833 — V-GRAD (March 21, 2025)
  • K242043 — Sperm Freezing Medium (January 8, 2025)
  • K241132 — ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) (December 18, 2024)