MQL — Media, Reproductive Class II

FDA Device Classification

Classification Details

Product Code
MQL
Device Class
Class II
Regulation Number
884.6180
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252672casebioscienceCaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)February 20, 2026
K250445fujifilm irvine scientificFast Warm - NXSeptember 12, 2025
K251637donnevie medical technology (shanghai) co.Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin August 27, 2025
K251305kitazato corporationUltra-Fast Vitri; Ultra-Fast WarmAugust 26, 2025
K242640fertiproFertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamiMay 30, 2025
K242089jiangsu ruifuda medical device coVitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)April 10, 2025
K242561donnevie medical technology (shanghai) co.Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)April 10, 2025
K241833vitromedV-GRADMarch 21, 2025
K242107casebioscienceCaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC);March 21, 2025
K242043gimbo medical technology shenzhen coSperm Freezing MediumJanuary 8, 2025
K241095artsmedia denmark apsARTSMedia Semen Wash MediumDecember 18, 2024
K241132artsmedia denmark apsARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)December 18, 2024
K242968gimbo medical technology shenzhen coGiftlife® Single-Step Medium PlusNovember 22, 2024
K240176vitromedV-VITFREEZE and V-VITWARMSeptember 13, 2024
K233846ecmpcVitrification Solution Set and Warming Solution SetAugust 27, 2024
K240605vitrolife swedenUltra RapidWarm™ BlastAugust 7, 2024
K233477shandong wego ruisheng medical device coCryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-July 1, 2024
K240149gimbo medical technology shenzhen coGiftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst June 13, 2024
K234023gimbo medical technology shenzhen coOocyte Flushing & Retrieval Medium; Gamete BufferMay 10, 2024
K233764fujifilm irvine scientificSSS-NX (Serum Substitute Supplement-NX)April 24, 2024