510(k) K251637
- Device
- Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
- Applicant
- Donnevie Medical Technology (Shanghai) Co. , Ltd.
- 510(k) number
- K251637
- Product code
- MQL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-27
- Date received
- 2025-05-29
- Regulation
- 884.6180
- Classification name
- Media, Reproductive
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Hannah Hang Yin
- Address
- Suite 201, Bld. 1, 138 Xinjun Ring Minhang District Shanghai CN 201114 201114
FDA Registration Numbers
- 3007800906
- 3004048494
- 3030681110
- 1221433
- 2022379
- 3025773437
- 3014755376
- 3003995932
- 3014295858
- 3021166069
- 3036725842
- 3003766921
- 3008876063
- 2031824
- 3005580113
- 3004882774
- 3003272500
- 3016126174
- 1216677
- 3007738736
- 3017896194
- 3018010054
- 3010413864
- 3033813683
- 3030390242
- 1222779
- 9616005
- 3003274090
- 3012853704
- 3015140190
- 3036495174
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code MQL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260248 | Ultra-Fast Warm | Kitazato Corporation | 2026-04-28 |
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | Casebioscience, Inc. | 2026-02-20 |
| K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | 2025-09-12 |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | 2025-08-26 |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV | 2025-05-30 |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-04-10 |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. | 2025-04-10 |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. | 2025-03-21 |
| K241833 | V-GRAD | Vitromed GmbH | 2025-03-21 |
| K242043 | Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | 2025-01-08 |
| K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps | 2024-12-18 |
| K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | 2024-12-18 |
| K242968 | Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-11-22 |
| K240176 | V-VITFREEZE and V-VITWARM | Vitromed GmbH | 2024-09-13 |
| K233846 | Vitrification Solution Set and Warming Solution Set | Ecmpc, LLC | 2024-08-27 |