Atlas FDA

MQL

259 FDA 510(k) clearances · Product code

128 daysmedian time to decision
312 days90th percentile
259clearances measured

FDA profile

Official device name
Media, Reproductive
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6180
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
1999: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Ultra-Fast Warm (K260248)Kitazato Corporation2026-04-28
CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (K252672)Casebioscience, Inc.2026-02-20
Fast Warm - NX (K250445)Fujifilm Irvine Scientific2025-09-12
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (K251637)Donnevie Medical Technology (Shanghai) Co. , Ltd.2025-08-27
Ultra-Fast Vitri; Ultra-Fast Warm (K251305)Kitazato Corporation2025-08-26
FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin (K242640)Fertipro NV2025-05-30
Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (K242089)Jiangsu Ruifuda Medical Device Co., Ltd.2025-04-10
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (K242561)Donnevie Medical Technology (Shanghai) Co. , Ltd.2025-04-10
CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) (K242107)Casebioscience, Inc.2025-03-21
V-GRAD (K241833)Vitromed GmbH2025-03-21
Sperm Freezing Medium (K242043)Gimbo Medical Technology Shenzhen Co., Ltd.2025-01-08
ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) (K241132)Artsmedia Denmark Aps2024-12-18
ARTSMedia Semen Wash Medium (K241095)Artsmedia Denmark Aps2024-12-18
Giftlife® Single-Step Medium Plus (K242968)Gimbo Medical Technology Shenzhen Co., Ltd.2024-11-22
V-VITFREEZE and V-VITWARM (K240176)Vitromed GmbH2024-09-13
Vitrification Solution Set and Warming Solution Set (K233846)Ecmpc, LLC2024-08-27
Ultra RapidWarm™ Blast (K240605)Vitrolife Sweden AB2024-08-07
Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) (K233477)Shandong Wego Ruisheng Medical Device Co., Ltd.2024-07-01
Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium (K240149)Gimbo Medical Technology Shenzhen Co., Ltd.2024-06-13
Oocyte Flushing & Retrieval Medium; Gamete Buffer (K234023)Gimbo Medical Technology Shenzhen Co., Ltd.2024-05-10
SSS-NX (Serum Substitute Supplement-NX) (K233764)Fujifilm Irvine Scientific2024-04-24
V-PVP (K232125)Vitromed GmbH2024-03-20
G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media (K232942)Gimbo Medical Technology Shenzhen Co., Ltd.2024-01-30
Dewin Blastocyst Medium (with HSA and without HSA) (K231370)Donnevie Medical Technology (Shanghai) Co. , Ltd.2023-08-04
V-HYADASE (K222606)Vitromed GmbH2023-05-26
CryoX Vitrification Freeze Kit / Thaw Kit (K223265)Zhejiang Horizon Medical Technology Co., Ltd.2023-05-11
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) (K220715)Artsmedia Denmark Aps2023-02-10
V-SPERM WASH (K223117)Vitromed GmbH2023-01-31
V-HEPES PLUS (K213293)Vitromed Langenfeld2022-09-14
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) (K212426)Donnevie Medical Technology (Shanghai) Co. , Ltd.2022-06-16
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium (K212410)Shenzhen Vitavitro Biotech Co., Ltd.2022-02-01
Gx-IVF, Gx-TL, Gx-MOPS PLUS (K202862)Vitrolife Sweden AB2021-05-14
V-ONESTEP (K193285)Vitromed GmbH2020-11-20
GM501 Wash with Phenol Red and Gentamicin (K192503)Hamilton Thorne Incorporated2020-11-19
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]) (K200249)Kitazato Corporation2020-10-23
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium (K200408)Shenzhen Vitavitro Biotech Co., Ltd.2020-10-16
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA (K193522)Kitazato Corporation2020-08-25
Sperm Freeze, Sperm Fridge (K192845)Kitazato Corporation2020-08-17
Synvitro Hyadase (K200680)Origio A/S, A Coopersurgical Company2020-07-17
GM501 SpermAir and GM501 SpermActive (K192644)Hamilton Thorne Incorporated2020-04-23
SepaSperm Washing Solution, SepaSperm Solution (K190199)Kitazato Corporation2019-09-26
GM501 Mineral Oil (K191552)Hamilton Thorne, Inc.2019-09-18
GM501 Wash (K190383)Hamilton Thorne, Inc.2019-09-05
1-Step Culture Medium (K191063)Shenzhen Vitavitro Biotech Co., Ltd.2019-08-23
RapidVit™ Oocyte, RapidWarm™ Oocyte (K183486)Vitrolife Sweden AB2019-07-26
Vit Kit- Freeze NX and Vit Kit- Warm NX (K190152)Fujifilm Irvine Scientific, Inc.2019-06-21
Cumulus Remover (K182002)Kitazato Corporation2018-10-23
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set (K180073)Shenzhen Vitavitro Bio-Tech Co., Ltd.2018-08-29
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) (K173731)CooperSurgical, Inc.2018-03-02
ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) (K173624)Origio A/S2018-03-02
Vitrification Kit and Thawing Kit (K171748)Kitazato Corporation2017-12-14
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS (K172197)Origio A/S2017-10-13
Gems Oocyte Retrieval Buffer ORB-20, ORB-50 (K170498)Genea Biomedx Pty, Ltd.2017-09-28
Arctic Sperm Cryopreservation Medium (K171224)Irvine Scientific Sales Co., Inc.2017-08-31
Continuous Single Culture -NX (CSCM-NX) (K170681)Irvine Scientific Sales Co., Inc.2017-06-08
Continuous Single Culture-NX Complete (CSCM-NXC) (K170602)Irvine Scientific Sales Co., Inc.2017-06-07
Gems Vitrification Set, Gems Warming Set (K162409)Genea Biomedx Pty, Ltd.2017-05-24
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase (K161261)Genea Biomedx Pty, Ltd.2017-05-12
SAGE Vitrification Kit and SAGE Vitrification Warming Kit (K170560)CooperSurgical, Inc.2017-04-04
Sydney IVF Culture Oil (K170257)William A. Cook Australia Pty. , Ltd.2017-02-24
Cryotop Vitrification Kit and Cryotop Thawing Kit (K160864)Kitazato Biopharma Co., Ltd.2016-10-07
Sydney IVF Gamete Buffer (K153478)William A. Cook Australia Pty. , Ltd.2016-08-15
PBS(-), Phosphate Buffered Saline (K160863)Kitazato Biopharma Co., Ltd.2016-07-28
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash (K153267)Origio A/S2016-07-22
Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit (K152717)William A. Cook Australia Pty. , Ltd.2016-05-06
Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit (K152682)Willian A. Cook Australia Pty, Ltd.2016-05-05
Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit (K160006)Irvine Scientific2016-05-04
Sydney IVF Sperm Cryopreservation Buffer (K160814)William A. Cook Australia Pty. , Ltd.2016-04-22
MINERAL OIL (K160142)Kitazato Biopharma Co., Ltd.2016-04-21
BlastGen (K152932)Origio A/S2016-02-29
Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium (K153290)William A. Cook Australia Pty. , Ltd.2016-01-27
Sydney IVF Hyaluronidase (K151367)William A. Cook Australia Pty. , Ltd.2016-01-27
SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT (K152782)William A. Cook Australia Pty. , Ltd.2015-12-21
FreezeKit Cleave , ThawKit Cleave (K150950)Vitrolife Sweden AB2015-12-21
SYDNEY IVF EMBRYO BIOPSY MEDIUM (K152904)William A. Cook Australia Pty. , Ltd.2015-12-03
Sydney IVF PVP (K152440)Willam A. Cook Australia Pty, Ltd.2015-09-23
COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit (K143724)William A. Cook Australia Pty. , Ltd.2015-08-27
LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA (K142991)Life Global Group, LLC2015-02-17
LifeGlobal Global HP (K143498)Life Global Group, LLC2015-01-20
G-TL (K133568)Vitrolife, Inc.2014-07-16
EMBRYOGEN (K140317)Origio A/S2014-06-16
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO (K133912)Origio A/S2014-05-14
ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED (K133387)Origio A/S2014-04-29
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS (K133707)Origio A/S2014-04-16
SPERMFREEZE SOLUTION (K113786)Vitrolife Sweden AB2012-10-26
EMBRYOGEN (K120136)Origio A/S2012-09-26
CONTINUOUS SINGLE CULTURE COMPLETE (K121572)Irvine Scientific Sales Co., Inc.2012-07-19
MULTIPURPOSE HANDLING MEDIUM (K121128)Irvine Scientific Sales Co., Inc.2012-06-06
LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES (K112083)<Genx> Intl., Inc.2012-05-03
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 (K092963)Genx Intl., Inc.2011-01-14
RAPIDVIT BLAST, RAPIDWARM BLAST (K101003)Vitrolife Sweden AB2010-12-10
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 (K100367)Origio A/S2010-08-27
VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 (K092107)Nidacon International AB2010-06-15
GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT (K092667)Genx Intl., Inc.2010-06-03
LIFEGLOBAL PROTEIN SUPPLEMENT (K092578)Genx Intl., Inc.2010-04-05
VIT KIT - FREEZE AND THAW (K093273)Irvine Scientific Sales Co., Inc.2010-03-03
COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS (K082363)William A. Cook Australia Pty. , Ltd.2009-04-29
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA (K083509)Genx Intl., Inc.2009-04-24
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 (K080172)Medicult A/S2008-12-18
RAPIDVIT AND RAPIDWARM CLEAVE (K080446)Vitrolife Sweden AB2008-11-26
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