Atlas FDA

MQG

46 FDA 510(k) clearances · Product code

126 daysmedian time to decision
415 days90th percentile
46clearances measured

FDA profile

Official device name
Accessory, Assisted Reproduction
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6120
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Vacuum Pump (Model: AD-VPUM-500) (K260194)Sheng Sheng Yi (Beijing) Technology Company Limited2026-04-28
Harioculture TL-16 Time-lapse Incubator (K242684)Hua Yue Medical Technology Co., Ltd.2025-05-22
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) (K232493)Wuhan Huchuang Union Technology Co., Ltd.2024-05-07
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (K180188)Genea Biomedx Pty, Ltd.2018-06-07
EmbryoScope+ (K173264)Vitrolife A/S2018-05-11
Geri Embryo Incubator and Geri Dish (K180304)Genea Biomedx Pty, Ltd.2018-04-20
Geri Embryo Incubator and Geri Dish (K171736)Genea Biomedx Pty, Ltd.2017-11-15
COOK Vacuum Pump (K160753)William A. Cook Australia Pty. , Ltd.2017-06-13
RI Witness Embryology Heated Plate (K160504)Research Instruments Limited2016-07-18
MIRI TL (K151357)At Medical Uab2016-04-22
EMBRYOVIEWER SOFTWARE (K133712)Unisense Fertilitech A/S2014-08-08
Origio Gas Line Filter (K132870)Origio, Inc.2014-05-07
XQ-1 INCUBATOR (K133742)At Medical Uab2014-04-23
PLANER BT37 INCUBATOR (K121566)Planer Plc2012-11-29
EMBRYO VIEWER SOFTWARE (K113075)Unisense Fertilitech A/S2011-12-21
EMBRYOSCOPE (K111715)Unisense Fertilitech A/S2011-08-11
HEAL FORCE CO2 INCUBATOR (K101988)Shanghai Lishen Scientific Equipment Co., Ltd.2011-02-08
EMBRYOSCOPE AND EMBRYOSLIDE (K092183)Unisense Fertilitech A/S2011-01-11
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 (K050197)Minitube of America, Inc.2006-10-06
ZIVF-AIRE (K041952)Zander Medical Supplies, Inc.2005-09-08
KRYO ART CONTROLLED RATE FREEZER (K032086)Planer Plc2004-03-19
BINDER CO2 INCUBATOR SERIE CB (K032526)Binder GmbH2003-08-29
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES (K030525)Mid-Atlantic Diagnostics, Inc.2003-08-27
KENDRO HERACELL 240 INCUBATOR (K023465)Kendro Laboratory Products, L.P.2003-03-10
DB1 EMBRYO FREEZE (K011327)Zander Medical Supplies, Inc.2002-08-15
WORKBENCH BY <GENX> (K020560)Genx Intl., Inc.2002-06-19
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 (K021042)Thermo Forma, Inc.2002-05-15
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) (K014160)Cook Urological, Inc.2002-02-08
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M (K013703)Sanyo North America Corp.2001-12-14
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 (K013401)K-Systems, Kivex Biotec , Ltd.2001-12-14
MTG - MINITUB HEATED STAGE SYSTEMS (K002971)Zander Medical Supplies, Inc.2000-12-15
<GENX> CODA INCUBATOR CELLMATE (K001600)<Genx> Intl., Inc.2000-11-22
MINITUB MULTI-PURPOSE CASSETTES (K002961)Zander Medical Supplies, Inc.2000-11-21
RS BIOTECH GALAXY 'R' CO2 INCUBATOR (K003184)Zander Medical Supplies, Inc.2000-11-20
CBS STRAW (K002595)Cryo Bio System2000-11-17
KENDRO HERACELL CO2 INCUBATOR (K002805)Kendro Laboratory Products, L.P.2000-11-09
GENX CODA AIR PURIFICATION SYSTEM (K001486)<Genx> Intl., Inc.2000-09-15
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS (K001524)Thermoquest Corp.2000-07-12
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT (K000394)Rocket Medical Plc2000-02-29
COOK ULTRA QUIET VACUUM PUMP & REGULATOR (K992070)Cook Urological, Inc.1999-10-27
HOFFMAN IVF-1 (K991216)(Arms) Hoffman Surgical Equipment, Ivf Division1999-08-05
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR (K991408)Thermoquest Corp.1999-07-19
THERMOPLATE (K991263)Tokai Hit Co., Ltd.1999-07-08
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L (K991229)Henning Knudsen Engineering A/S1999-06-29
COOK MINI-INCUBATOR (K983642)Cook Ob/Gyn1999-02-01
COOK TEST TUBE HEATER (K983609)Cook Ob/Gyn1998-12-16

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