FDA product code MQK: Labware, Assisted Reproduction
MQK is the FDA product code for labware, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6160 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 50 510(k) submissions under MQK, 9 in the last five years, from 36 different applicants. The average 510(k) review took 188 days (median 163); 210 days on average over the last three years. FDA has posted 4 recalls for MQK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Labware, Assisted Reproduction |
| Device class | Class II |
| Regulation | 21 CFR 884.6160 |
| 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 MQK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 204 |
| 2018 | 4 | 128 |
| 2019 | 1 | 214 |
| 2020 | 2 | 156 |
| 2021 | 1 | 175 |
| 2022 | 2 | 110 |
| 2024 | 4 | 159 |
| 2025 | 3 | 260 |
Compare with all 510(k) review times · Search every MQK clearance
Top MQK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Origio A/S | 3 | 2020-06-25 |
| Vitrolife Sweden AB | 3 | 2019-01-04 |
| Becton Dickinson Labware | 3 | 1999-05-05 |
| Vitrolife A/S | 2 | 2022-03-11 |
| Reprobitech Corp. | 2 | 2018-02-09 |
31 more applicants have MQK clearances. See the full list in Caduvo.
Most recent MQK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241626 | Ipreg Incorporation | SperSort Sperm Sorting Chip (IPG02) | 2025-02-20 | 259 |
| K241454 | Guangzhou Hehong Biotech Co., Ltd. | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) | 2025-02-03 | 257 |
| K241348 | Motilitycount Aps | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | 2025-01-31 | 263 |
| K241341 | Fujifilm Irvine Scientific | cryo-GO Vitrification Device | 2024-09-26 | 136 |
| K240002 | Gimbo Medical Technology Shenzhen Co., Ltd. | G-Vitri Vitrification Straw | 2024-06-14 | 164 |
Recalls for MQK devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-04-01.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code MQK?
MQK is the FDA product code for labware, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6160 and reviewed by the Obstetrics and Gynecology panel.
What device class is MQK?
Class II, regulation 21 CFR 884.6160. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQK?
Across 50 cleared submissions the average was 188 days from receipt to decision (median 163).
Which companies have the most MQK clearances?
Origio A/S (3); Vitrolife Sweden AB (3); Becton Dickinson Labware (3); Vitrolife A/S (2); Reprobitech Corp. (2).
Have MQK devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2022-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code MQK
- Run a recall and safety report across every MQK manufacturer
- Watch product code MQK 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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