MQL — Media, Reproductive Class II
FDA product code MQL covers "Media, Reproductive", a Class II medical device regulated under 21 CFR 884.6180. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MQL
- Device Class
- Class II
- Regulation Number
- 884.6180
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260248 | kitazato corporation | Ultra-Fast Warm | April 28, 2026 |
| K252672 | casebioscience | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | February 20, 2026 |
| K250445 | fujifilm irvine scientific | Fast Warm - NX | September 12, 2025 |
| K251637 | donnevie medical technology (shanghai) co. | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin | August 27, 2025 |
| K251305 | kitazato corporation | Ultra-Fast Vitri; Ultra-Fast Warm | August 26, 2025 |
| K242640 | fertipro | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentami | May 30, 2025 |
| K242561 | donnevie medical technology (shanghai) co. | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | April 10, 2025 |
| K242089 | jiangsu ruifuda medical device co | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | April 10, 2025 |
| K242107 | casebioscience | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); | March 21, 2025 |
| K241833 | vitromed | V-GRAD | March 21, 2025 |
| K242043 | gimbo medical technology shenzhen co | Sperm Freezing Medium | January 8, 2025 |
| K241095 | artsmedia denmark aps | ARTSMedia Semen Wash Medium | December 18, 2024 |
| K241132 | artsmedia denmark aps | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | December 18, 2024 |
| K242968 | gimbo medical technology shenzhen co | Giftlife® Single-Step Medium Plus | November 22, 2024 |
| K240176 | vitromed | V-VITFREEZE and V-VITWARM | September 13, 2024 |
| K233846 | ecmpc | Vitrification Solution Set and Warming Solution Set | August 27, 2024 |
| K240605 | vitrolife sweden | Ultra RapidWarm Blast | August 7, 2024 |
| K233477 | shandong wego ruisheng medical device co | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A- | July 1, 2024 |
| K240149 | gimbo medical technology shenzhen co | Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst | June 13, 2024 |
| K234023 | gimbo medical technology shenzhen co | Oocyte Flushing & Retrieval Medium; Gamete Buffer | May 10, 2024 |