Accessory, Assisted Reproduction
FDA product code MQG · Class II (moderate risk) · 21 CFR 884.6120 · Obstetrics/Gynecology
47510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Zander Medical Supplies, Inc. 5
- Unisense Fertilitech A/S 4
- Genea Biomedx Pty, Ltd. 3
- <Genx> Intl., Inc. 3
- At Medical Uab 2
- Cook Ob/Gyn 2
- Planer Plc 2
- Kendro Laboratory Products, L.P. 2
- Cook Urological, Inc. 2
- Thermoquest Corp. 2
- Rocket Medical Plc 1
- Cryo Bio System 1
- K-Systems, Kivex Biotec , Ltd. 1
- Sanyo North America Corp. 1
- Thermo Forma, Inc. 1
- Mid-Atlantic Diagnostics, Inc. 1
- Binder GmbH 1
- (Arms) Hoffman Surgical Equipment, Ivf Division 1
- CooperSurgical, Inc. 1
- Tokai Hit Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…MQG · Traditional | CooperSurgical, Inc. | 08/19/2026SE |
| K260194 | Vacuum Pump (Model: AD-VPUM-500)MQG · Traditional | Sheng Sheng Yi (Beijing) Technology Company… | 04/28/2026SE |
| K242684 | Harioculture TL-16 Time-lapse IncubatorMQG · Traditional | Hua Yue Medical Technology Co., Ltd. | 05/22/2025SE |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)MQG · Traditional | Wuhan Huchuang Union Technology Co., Ltd. | 05/07/2024SE |
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG · Traditional | Genea Biomedx Pty, Ltd. | 06/07/2018SE |
| K173264 | EmbryoScope+MQG · Traditional | Vitrolife A/S | 05/11/2018SE |
| K180304 | Geri Embryo Incubator and Geri DishMQG · Special | Genea Biomedx Pty, Ltd. | 04/20/2018SE |
| K171736 | Geri Embryo Incubator and Geri DishMQG · Traditional | Genea Biomedx Pty, Ltd. | 11/15/2017SE |
| K160753 | COOK Vacuum PumpMQG · Traditional | William A. Cook Australia Pty. , Ltd. | 06/13/2017SE |
| K160504 | RI Witness Embryology Heated PlateMQG · Traditional | Research Instruments Limited | 07/18/2016SE |
| K151357 | Miri TLMQG · Traditional | At Medical Uab | 04/22/2016SE |
| K133712 | Embryoviewer SoftwareMQG · Traditional | Unisense Fertilitech A/S | 08/08/2014SE |
| K132870 | Origio Gas Line FilterMQG · Traditional | Origio, Inc. | 05/07/2014SE |
| K133742 | XQ-1 IncubatorMQG · Traditional | At Medical Uab | 04/23/2014SE |
| K121566 | Planer BT37 IncubatorMQG · Traditional | Planer Plc | 11/29/2012SE |
| K113075 | Embryo Viewer SoftwareMQG · Traditional | Unisense Fertilitech A/S | 12/21/2011SE |
| K111715 | EmbryoscopeMQG · Traditional | Unisense Fertilitech A/S | 08/11/2011SE |
| K101988 | Heal Force CO2 IncubatorMQG · Traditional | Shanghai Lishen Scientific Equipment Co., Ltd. | 02/08/2011SE |
| K092183 | Embryoscope and EmbryoslideMQG · Traditional | Unisense Fertilitech A/S | 01/11/2011SE |
| K050197 | Minitube Temperature Control Unit SC-2000 + 2045MQG · Traditional | Minitube of America, Inc. | 10/06/2006SE |
| K041952 | Zivf-AireMQG · Traditional | Zander Medical Supplies, Inc. | 09/08/2005SE |
| K032086 | Kryo Art Controlled Rate FreezerMQG · Traditional | Planer Plc | 03/19/2004SE |
| K032526 | Binder CO2 Incubator Serie CBMQG · Traditional | Binder GmbH | 08/29/2003SE |
| K030525 | Custom Products Ivf Workstation Type WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 and…MQG · Traditional | Mid-Atlantic Diagnostics, Inc. | 08/27/2003SE |
| K023465 | Kendro Heracell 240 IncubatorMQG · Traditional | Kendro Laboratory Products, L.P. | 03/10/2003SE |
| K011327 | DB1 Embryo FreezeMQG · Traditional | Zander Medical Supplies, Inc. | 08/15/2002SE |
| K020560 | Workbench by <Genx>MQG · Traditional | Genx Intl., Inc. | 06/19/2002SE |
| K021042 | Thermo Forma, Cryomed, Controlled Rate Freezers; Models # 7456, 7457, 7458,7459,7475,7476MQG · Traditional | Thermo Forma, Inc. | 05/15/2002SE |
| K014160 | Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)MQG · Traditional | Cook Urological, Inc. | 02/08/2002SE |
| K013703 | Sanyo CO2 Incubators, Models Nos. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175MMQG · Traditional | Sanyo North America Corp. | 12/14/2001SE |
| K013401 | K-Systems Culture Bag Sealer and Culture Bags Type CBS-1 and CB-01MQG · Traditional | K-Systems, Kivex Biotec , Ltd. | 12/14/2001SE |
| K002971 | MTG - Minitub Heated Stage SystemsMQG · Traditional | Zander Medical Supplies, Inc. | 12/15/2000SE |
| K001600 | <Genx> Coda Incubator CellmateMQG · Traditional | <Genx> Intl., Inc. | 11/22/2000SE |
| K002961 | Minitub Multi-Purpose CassettesMQG · Traditional | Zander Medical Supplies, Inc. | 11/21/2000SE |
| K003184 | RS Biotech Galaxy 'R' CO2 IncubatorMQG · Traditional | Zander Medical Supplies, Inc. | 11/20/2000SE |
| K002595 | CBS StrawMQG · Traditional | Cryo Bio System | 11/17/2000SE |
| K002805 | Kendro Heracell CO2 IncubatorMQG · Traditional | Kendro Laboratory Products, L.P. | 11/09/2000SE |
| K001486 | Genx Coda Air Purification SystemMQG · Traditional | <Genx> Intl., Inc. | 09/15/2000SE |
| K001524 | Forma Scientific Direct Heat IncubatorsMQG · Traditional | Thermoquest Corp. | 07/12/2000SE |
| K000394 | Craft Duo-Vac Suction Unit and Craft Suction UnitMQG · Traditional | Rocket Medical Plc | 02/29/2000SE |
| K992070 | Cook Ultra Quiet Vacuum Pump & RegulatorMQG · Traditional | Cook Urological, Inc. | 10/27/1999SE |
| K991216 | Hoffman IVF-1MQG · Traditional | (Arms) Hoffman Surgical Equipment, Ivf Division | 08/05/1999SE |
| K991408 | Forma Scientific Universal Water-Jacketed IncubatorMQG · Traditional | Thermoquest Corp. | 07/19/1999SE |
| K991263 | ThermoplateMQG · Traditional | Tokai Hit Co., Ltd. | 07/08/1999SE |
| K991229 | K-Systems Work Stations, Type L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24…MQG · Traditional | Henning Knudsen Engineering A/S | 06/29/1999SE |
| K983642 | Cook Mini-IncubatorMQG · Traditional | Cook Ob/Gyn | 02/01/1999SE |
| K983609 | Cook Test Tube HeaterMQG · Traditional | Cook Ob/Gyn | 12/16/1998SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0722-2024 Class II | MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN)…The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static… | Cook Medical Llc | 12/07/2023Open, Classified |
| Z-1823-2022 Class II | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop…There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of… | CooperSurgical, Inc. | 08/12/2022Open, Classified |
| Z-1822-2022 Class II | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop…There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of… | CooperSurgical, Inc. | 08/12/2022Open, Classified |
| Z-0809-2021 Class II | Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause… | Cook Medical Llc | 12/16/2020Terminated |
| Z-0029-2020 Class III | Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, &…The touchpad may not work properly after cleaning. | CooperSurgical, Inc. | 09/05/2019Terminated |
| Z-1461-2018 Class II | Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the…Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and… | Cook Inc. | 03/22/2018Terminated |
| Z-1460-2018 Class II | Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the…Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and… | Cook Inc. | 03/22/2018Terminated |
| Z-1378-2018 Class II | MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a…The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for… | Cook Inc. | 01/12/2018Terminated |
| Z-1377-2018 Class II | MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a…The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for… | Cook Inc. | 01/12/2018Terminated |