FDA product code MQE: Needle, Assisted Reproduction
MQE is the FDA product code for needle, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6100 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 33 510(k) submissions under MQE, 3 in the last five years, from 24 different applicants. The average 510(k) review took 149 days (median 138); 252 days on average over the last three years. FDA has posted 1 recall for MQE devices.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Assisted Reproduction |
| Device class | Class II |
| Regulation | 21 CFR 884.6100 |
| 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 MQE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 234 |
| 2018 | 1 | 224 |
| 2019 | 3 | 163 |
| 2024 | 2 | 241 |
| 2026 | 1 | 263 |
Compare with all 510(k) review times · Search every MQE clearance
Top MQE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| CooperSurgical, Inc. | 3 | 2019-06-12 |
| Vitrolife Sweden AB | 3 | 2017-11-21 |
| <Genx> Intl., Inc. | 3 | 1999-09-09 |
| William A. Cook Australia Pty. , Ltd. | 2 | 2017-12-15 |
| Rocket Medical Plc | 2 | 2003-08-08 |
19 more applicants have MQE clearances. See the full list in Caduvo.
Most recent MQE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253121 | Gimbo Medical Technology Shenzhen Co., Ltd. | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | 2026-06-15 | 263 |
| K240523 | Shenzhen Vitavitro Biotech Co., Ltd. | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) | 2024-11-15 | 266 |
| K232163 | Zhejiang Horizon Medical Technology Co., Ltd. | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle | 2024-02-22 | 216 |
| K190590 | Allwin Medical Devices, Inc. | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) | 2019-11-25 | 263 |
| K191291 | CooperSurgical, Inc. | Wallace Dual Lumen Oocyte Recovery System | 2019-06-12 | 29 |
Recalls for MQE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-10-23.
Frequently asked questions
What is FDA product code MQE?
MQE is the FDA product code for needle, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6100 and reviewed by the Obstetrics and Gynecology panel.
What device class is MQE?
Class II, regulation 21 CFR 884.6100. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQE?
Across 33 cleared submissions the average was 149 days from receipt to decision (median 138).
Which companies have the most MQE clearances?
CooperSurgical, Inc. (3); Vitrolife Sweden AB (3); <Genx> Intl., Inc. (3); William A. Cook Australia Pty. , Ltd. (2); Rocket Medical Plc (2).
Have MQE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-10-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MQE
- Run a recall and safety report across every MQE manufacturer
- Watch product code MQE 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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