FDA product code MQG: Accessory, Assisted Reproduction
MQG is the FDA product code for accessory, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6120 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 47 510(k) submissions under MQG, 4 in the last five years, from 31 different applicants. The average 510(k) review took 165 days (median 126); 213 days on average over the last three years. FDA has posted 9 recalls for MQG devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessory, Assisted Reproduction |
| Device class | Class II |
| Regulation | 21 CFR 884.6120 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MQG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 304 |
| 2018 | 3 | 141 |
| 2024 | 1 | 264 |
| 2025 | 1 | 258 |
| 2026 | 2 | 118 |
Compare with all 510(k) review times · Search every MQG clearance
Top MQG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zander Medical Supplies, Inc. | 5 | 2005-09-08 |
| Unisense Fertilitech A/S | 4 | 2014-08-08 |
| Genea Biomedx Pty, Ltd. | 3 | 2018-06-07 |
| At Medical Uab | 2 | 2016-04-22 |
| Planer Plc | 2 | 2012-11-29 |
26 more applicants have MQG clearances. See the full list in Caduvo.
Most recent MQG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261083 | CooperSurgical, Inc. | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) | 2026-08-19 | 140 |
| K260194 | Sheng Sheng Yi (Beijing) Technology Company Limited | Vacuum Pump (Model: AD-VPUM-500) | 2026-04-28 | 96 |
| K242684 | Hua Yue Medical Technology Co., Ltd. | Harioculture TL-16 Time-lapse Incubator | 2025-05-22 | 258 |
| K232493 | Wuhan Huchuang Union Technology Co., Ltd. | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | 2024-05-07 | 264 |
| K180188 | Genea Biomedx Pty, Ltd. | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | 2018-06-07 | 135 |
Recalls for MQG devices
9 product recalls in 6 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-12-07.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code MQG?
MQG is the FDA product code for accessory, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6120 and reviewed by the Obstetrics and Gynecology panel.
What device class is MQG?
Class II, regulation 21 CFR 884.6120. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQG?
Across 47 cleared submissions the average was 165 days from receipt to decision (median 126).
Which companies have the most MQG clearances?
Zander Medical Supplies, Inc. (5); Unisense Fertilitech A/S (4); Genea Biomedx Pty, Ltd. (3); At Medical Uab (2); Planer Plc (2).
Have MQG devices been recalled?
Yes: 9 product recalls across 6 recall events; the most recent began 2023-12-07.
Next steps
- Run an FDA pathway report with predicate devices for product code MQG
- Run a recall and safety report across every MQG manufacturer
- Watch product code MQG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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