MQL · Media, Reproductive
Obstetrics/Gynecology · 21 CFR 884.6180 · Class 2
Overview
| Product Code | MQL |
|---|---|
| Device Name | Media, Reproductive |
| Regulation | 21 CFR 884.6180 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (20 of 258)
Showing 20 most recent of 258 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | Casebioscience, Inc. | Feb 20, 2026 | SESE |
| K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | Sep 12, 2025 | SESE |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | Aug 27, 2025 | SESE |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | Aug 26, 2025 | SESE |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV | May 30, 2025 | SESE |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | Apr 10, 2025 | SESE |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. | Apr 10, 2025 | SESE |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. | Mar 21, 2025 | SESE |
| K241833 | V-GRAD | Vitromed GmbH | Mar 21, 2025 | SESE |
| K242043 | Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | Jan 8, 2025 | SESE |
| K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps | Dec 18, 2024 | SESE |
| K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | Dec 18, 2024 | SESE |
| K242968 | Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. | Nov 22, 2024 | SESE |
| K240176 | V-VITFREEZE and V-VITWARM | Vitromed GmbH | Sep 13, 2024 | SESE |
| K233846 | Vitrification Solution Set and Warming Solution Set | Ecmpc, LLC | Aug 27, 2024 | SESE |
| K240605 | Ultra RapidWarm Blast | Vitrolife Sweden AB | Aug 7, 2024 | SESE |
| K233477 | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) | Shandong Wego Ruisheng Medical Device Co., Ltd. | Jul 1, 2024 | SESE |
| K240149 | Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | Jun 13, 2024 | SESE |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | Gimbo Medical Technology Shenzhen Co., Ltd. | May 10, 2024 | SESE |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | Fujifilm Irvine Scientific | Apr 24, 2024 | SESE |
Top Applicants
- Irvine Scientific Sales Co., Inc. — 36 clearances
- Vitrolife Sweden AB — 28 clearances
- Medicult A/S — 26 clearances
- <Genx> Intl., Inc. — 15 clearances
- Nidacon International AB — 11 clearances
