MQL
- Product code
- MQL
- Device name
- Media, Reproductive
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 260
510(k) clearances, last 3 years (24)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254261 | 2026-08-28 | CELL STORE (BEIJING) BIOTECHNOLOGY CO. | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; | |
| K260248 | 2026-04-28 | Kitazato Corporation | Ultra-Fast Warm | |
| K252672 | 2026-02-20 | Casebioscience, Inc. | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/H | |
| K250445 | 2025-09-12 | Fujifilm Irvine Scientific | Fast Warm - NX | |
| K251637 | 2025-08-27 | Donnevie Medical Technology (Shanghai) | Dewin Reproductive Media (Dewin Gamete Buffer [with | |
| K251305 | 2025-08-26 | Kitazato Corporation | Ultra-Fast Vitri; Ultra-Fast Warm | |
| K242640 | 2025-05-30 | Fertipro NV | FertiCult Flushing medium; FertiCult Flushing medium | |
| K242561 | 2025-04-10 | Donnevie Medical Technology (Shanghai) | Dewin Reproductive Media (Dewin Vitrification Kit, D | |
| K242089 | 2025-04-10 | Jiangsu Ruifuda Medical Device Co., Lt | Vitrification Freeze Kit (RFD-0101) Vitrification Th | |
| K241833 | 2025-03-21 | Vitromed GmbH | V-GRAD | |
| K242107 | 2025-03-21 | Casebioscience, Inc. | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); | |
| K242043 | 2025-01-08 | Gimbo Medical Technology Shenzhen Co., | Sperm Freezing Medium | — |
| K241132 | 2024-12-18 | Artsmedia Denmark Aps | ARTSMedia Oocyte Aspiration Medium (502020, 502050, | |
| K241095 | 2024-12-18 | Artsmedia Denmark Aps | ARTSMedia Semen Wash Medium | |
| K242968 | 2024-11-22 | Gimbo Medical Technology Shenzhen Co., | Giftlife® Single-Step Medium Plus | — |
| K240176 | 2024-09-13 | Vitromed GmbH | V-VITFREEZE and V-VITWARM | |
| K233846 | 2024-08-27 | Ecmpc, LLC | Vitrification Solution Set and Warming Solution Set | |
| K240605 | 2024-08-07 | Vitrolife Sweden AB | Ultra RapidWarm Blast | |
| K233477 | 2024-07-01 | Shandong Wego Ruisheng Medical Device | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B | |
| K240149 | 2024-06-13 | Gimbo Medical Technology Shenzhen Co., | Giftlife Fertilization Medium; Giftlife Cleavage M | — |
| K234023 | 2024-05-10 | Gimbo Medical Technology Shenzhen Co., | Oocyte Flushing & Retrieval Medium; Gamete Buffer | — |
| K233764 | 2024-04-24 | Fujifilm Irvine Scientific | SSS-NX (Serum Substitute Supplement-NX) | |
| K232125 | 2024-03-20 | Vitromed GmbH | V-PVP | |
| K232942 | 2024-01-30 | Gimbo Medical Technology Shenzhen Co., | G-Vitri Vitrification Freeze Media; G-Vitri Vitrif | — |
Official FDA classification page: MQL
Classification and pathway per current FDA publications. Data from openFDA (CC0).