FDA product code MQH: Microtools, Assisted Reproduction (Pipettes)
MQH is the FDA product code for microtools, assisted reproduction (pipettes). It is a Class II device, regulated under 21 CFR 884.6130 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 26 510(k) submissions under MQH, 1 in the last five years, from 19 different applicants. The average 510(k) review took 153 days (median 134); 105 days on average over the last three years. FDA has posted 4 recalls for MQH devices.
Classification
| Field | Value |
|---|---|
| Device name | Microtools, Assisted Reproduction (Pipettes) |
| Device class | Class II |
| Regulation | 21 CFR 884.6130 |
| 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 MQH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 262 |
| 2020 | 1 | 173 |
| 2025 | 1 | 105 |
Compare with all 510(k) review times · Search every MQH clearance
Top MQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 2 | 2016-01-08 |
| Research Instruments , Ltd. | 2 | 2014-05-16 |
| Sunlight Medical, Inc. | 2 | 2010-04-30 |
| Mid-Atlantic Diagnostics, Inc. | 2 | 2004-09-29 |
| Cook Urological, Inc. | 2 | 2004-01-16 |
14 more applicants have MQH clearances. See the full list in Caduvo.
Most recent MQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250838 | Guangzhou Pinzhi Medical Device Co., Ltd. | Denudation Pipettes | 2025-07-03 | 105 |
| K192146 | Vitromed GmbH | V-DENUPET | 2020-01-28 | 173 |
| K161275 | Research Instruments Limited | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | 2017-01-23 | 262 |
| K152581 | Life Global Group, LLC | LifeGlobal Micro Tips | 2016-04-11 | 214 |
| K151018 | Cook Incorporated | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette | 2016-01-08 | 267 |
Recalls for MQH devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-03-27.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code MQH?
MQH is the FDA product code for microtools, assisted reproduction (pipettes). It is a Class II device, regulated under 21 CFR 884.6130 and reviewed by the Obstetrics and Gynecology panel.
What device class is MQH?
Class II, regulation 21 CFR 884.6130. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQH?
Across 26 cleared submissions the average was 153 days from receipt to decision (median 134).
Which companies have the most MQH clearances?
Cook Incorporated (2); Research Instruments , Ltd. (2); Sunlight Medical, Inc. (2); Mid-Atlantic Diagnostics, Inc. (2); Cook Urological, Inc. (2).
Have MQH devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2019-03-27.
Next steps
- Run an FDA pathway report with predicate devices for product code MQH
- Run a recall and safety report across every MQH manufacturer
- Watch product code MQH 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.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times