MQK
- Product code
- MQK
- Device name
- Labware, Assisted Reproduction
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.6160
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 50 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241626 | 2025-02-20 | Ipreg Incorporation | SperSort Sperm Sorting Chip (IPG02) | |
| K241454 | 2025-02-03 | Guangzhou Hehong Biotech Co., Ltd. | Minvitro® Vitrification Straw (MVT-VSN series, inclu… | |
| K241348 | 2025-01-31 | Motilitycount Aps | SwimCount® Harvester (1 mL); SwimCount® Harvester (3… | |
| K241341 | 2024-09-26 | Fujifilm Irvine Scientific | cryo-GO Vitrification Device | |
| K240002 | 2024-06-14 | Gimbo Medical Technology Shenzhen Co.,… | G-Vitri Vitrification Straw | — |
| K232980 | 2024-03-14 | Cytoswim, Ltd. | SpermAlign Sperm Separation Device | |
| K233177 | 2024-03-08 | Cook Incorporated | Nest VT Vitrification Device |
Official FDA classification page: MQK
Classification and pathway per current FDA publications. Data from openFDA (CC0).