MQG · Accessory, Assisted Reproduction
Obstetrics/Gynecology · 21 CFR 884.6120 · Class 2
Overview
| Product Code | MQG |
|---|---|
| Device Name | Accessory, Assisted Reproduction |
| Regulation | 21 CFR 884.6120 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova). (2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures. (3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation. (4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature. (5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
Classification Rationale
Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242684 | Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. | May 22, 2025 | SESE |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | Wuhan Huchuang Union Technology Co., Ltd. | May 7, 2024 | SESE |
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | Genea Biomedx Pty, Ltd. | Jun 7, 2018 | SESE |
| K173264 | EmbryoScope+ | Vitrolife A/S | May 11, 2018 | SESE |
| K180304 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | Apr 20, 2018 | SESE |
| K171736 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | Nov 15, 2017 | SESE |
| K160753 | COOK Vacuum Pump | William A. Cook Australia Pty. , Ltd. | Jun 13, 2017 | SESE |
| K160504 | RI Witness Embryology Heated Plate | Research Instruments Limited | Jul 18, 2016 | SESE |
| K151357 | MIRI TL | At Medical Uab | Apr 22, 2016 | SESE |
| K133712 | EMBRYOVIEWER SOFTWARE | Unisense Fertilitech A/S | Aug 8, 2014 | SESE |
| K132870 | Origio Gas Line Filter | Origio, Inc. | May 7, 2014 | SESE |
| K133742 | XQ-1 INCUBATOR | At Medical Uab | Apr 23, 2014 | SESE |
| K121566 | PLANER BT37 INCUBATOR | Planer Plc | Nov 29, 2012 | SESE |
| K113075 | EMBRYO VIEWER SOFTWARE | Unisense Fertilitech A/S | Dec 21, 2011 | SESE |
| K111715 | EMBRYOSCOPE | Unisense Fertilitech A/S | Aug 11, 2011 | SESE |
| K101988 | HEAL FORCE CO2 INCUBATOR | Shanghai Lishen Scientific Equipment Co., Ltd. | Feb 8, 2011 | SESE |
| K092183 | EMBRYOSCOPE AND EMBRYOSLIDE | Unisense Fertilitech A/S | Jan 11, 2011 | SESE |
| K050197 | MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 | Minitube of America, Inc. | Oct 6, 2006 | SESE |
| K041952 | ZIVF-AIRE | Zander Medical Supplies, Inc. | Sep 8, 2005 | SESE |
| K032086 | KRYO ART CONTROLLED RATE FREEZER | Planer Plc | Mar 19, 2004 | SESE |
Top Applicants
- Zander Medical Supplies, Inc. — 5 clearances
- Unisense Fertilitech A/S — 4 clearances
- Genea Biomedx Pty, Ltd. — 3 clearances
- <Genx> Intl., Inc. — 2 clearances
- At Medical Uab — 2 clearances
