Atlas FDA

MQK

50 FDA 510(k) clearances · Product code

164 daysmedian time to decision
326 days90th percentile
50clearances measured

FDA profile

Official device name
Labware, Assisted Reproduction
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6160
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
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RecordFirmDate
SperSort™ Sperm Sorting Chip (IPG02) (K241626)Ipreg Incorporation2025-02-20
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (K241454)Guangzhou Hehong Biotech Co., Ltd.2025-02-03
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (K241348)Motilitycount Aps2025-01-31
cryo-GO Vitrification Device (K241341)Fujifilm Irvine Scientific2024-09-26
G-Vitri™ Vitrification Straw (K240002)Gimbo Medical Technology Shenzhen Co., Ltd.2024-06-14
SpermAlign Sperm Separation Device (K232980)Cytoswim, Ltd.2024-03-14
Nest VT Vitrification Device (K233177)Cook Incorporated2024-03-08
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device (K221810)Bonraybio Co., Ltd.2022-10-31
EmbryoSlide+ ic8 dish (K213869)Vitrolife A/S2022-03-11
SureStrip Vitrification Straw, SureLock Vitrification Straw (K203626)Allwin Medical Devices, Inc.2021-06-04
Pasteur Pipette 3mL, Pasteur Pipette 1mL (K201213)Hertart Aps2020-12-16
VitriGuard (K200815)Origio A/S2020-06-25
Rapid-i™ Kit (K181461)Vitrolife Sweden AB2019-01-04
Cryotop®US-flash and Cryotop®US-scoop (K181469)Kitazato Corporation2018-11-09
VitriGuard (K180740)Origio A/S2018-05-04
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) (K173075)Dxnow, Inc.2018-03-08
iVitri Straw (K172751)Reprobitech Corp.2018-02-09
iVitri EZ (K162640)Reprobitech Corp.2017-06-30
VitriGuard (K162833)Origio A/S2017-02-16
Cryotec (K162051)Reprolife, Inc.2016-12-14
Cryotop US (K153027)Kitazato Biopharma Co., Ltd.2016-03-14
EmbryoSlide Culture Dish (K150961)Vitrolife A/S2015-12-04
Micro well group culture dish, 9-well; Micro well group culture dish, 16-well (K150756)Hertart2015-07-20
RAPID-I KIT (K140207)Vitrolife Sweden AB2014-12-18
EEVA DISH (WITH 12 MICROWELLS) (K141663)Auxogyn, Inc.2014-07-22
QUALIS (K133295)Menicon Co., Ltd. New Business Division2014-06-18
CRYOTOP(R) SC (K140072)Kitazato Biopharma Co., Ltd.2014-04-03
PROINSERT (K131145)Nidacon International AB2014-02-20
CRYOLOCK (K122982)Biotech, Inc.2014-01-09
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH (K123641)Hertart2013-07-03
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM (K112644)Lotus Bio, Ltd.2012-12-19
CRYOTOP (K112695)Kitazato Biopharma Co;Ltd2012-12-12
RI MSC (MIGRATION SEDIMENTATION CHAMBER) (K112413)Research Instruments , Ltd.2012-07-13
EEVATM PETRI DISH (K103028)Auxogyn, Inc.2011-08-11
CRYOPETTE (K100596)Mid-Atlantic Diagnostics, Inc.2010-12-06
HSV STRAW (K092398)Cryo Bio System2010-10-06
RAPID-I (K090832)Vitrolife Sweden AB2009-12-23
NUNC IVF CENTERWELL AND ICSI DISHES (K090429)Thermo Fisher Scientific (Nalge Nunc Intl)2009-09-18
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH (K081896)Biogenics, Inc.2008-08-20
SUNIVF DISHES (K080395)<Genx> Intl., Inc.2008-08-13
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH (K070047)Nunc A/S2007-05-18
PICSI SPERM SELECTION DEVICE (K052457)Biocoat, Inc.2006-04-13
NUNC IVF MULTIDISH 4 WELLS NUNCLON (K040717)Nunc A/S2004-08-12
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 (K000915)Humagen Fertility Diagnostics, Inc.2000-05-12
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL (K994361)Genesis Industries, Inc.2000-02-18
GENX CULTURE DISH (K993881)<Genx> Intl., Inc.2000-02-14
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L (K990941)Humagen Fertility Diagnostics, Inc.1999-07-14
FALCON IVF ONE WELL DISH (K991251)Becton Dickinson Labware1999-05-05
FALCON IVF FOUR WELL PLATE (K991249)Becton Dickinson Labware1999-05-05
FALCON IVF ROUND DISH (K991253)Becton Dickinson Labware1999-05-05

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Every clearance here is in the API, with alerts when new ones post.