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510(k) K193522

Device
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
Applicant
Kitazato Corporation
510(k) number
K193522
Product code
MQL
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-25
Date received
2019-12-19
Regulation
884.6180
Classification name
Media, Reproductive
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Futoshi Inoue
Address
81 Nakajima Fuji-Shi JP 416-0907 416-0907

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260248Ultra-Fast WarmKitazato Corporation2026-04-28
K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.2026-02-20
K250445Fast Warm - NXFujifilm Irvine Scientific2025-09-12
K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.2025-08-27
K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation2025-08-26
K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV2025-05-30
K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)Donnevie Medical Technology (Shanghai) Co. , Ltd.2025-04-10
K242089Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)Jiangsu Ruifuda Medical Device Co., Ltd.2025-04-10
K242107CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)Casebioscience, Inc.2025-03-21
K241833V-GRADVitromed GmbH2025-03-21
K242043Sperm Freezing MediumGimbo Medical Technology Shenzhen Co., Ltd.2025-01-08
K241132ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)Artsmedia Denmark Aps2024-12-18
K241095ARTSMedia Semen Wash MediumArtsmedia Denmark Aps2024-12-18
K242968Giftlife® Single-Step Medium PlusGimbo Medical Technology Shenzhen Co., Ltd.2024-11-22
K240176V-VITFREEZE and V-VITWARMVitromed GmbH2024-09-13