FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
K Number: K242561
·
Decision Apr 10, 2025
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
4
Review Days
225
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Basic Information
- Device Name
- Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
- K Number
- K242561
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Donnevie Medical Technology (Shanghai) Co. , Ltd.
- Date Received
- August 28, 2024
- Decision Date
- April 10, 2025
- Product Code
- MQL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQL), ordered by most recent decision date.
Ultra-Fast Warm
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CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
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Fast Warm - NX
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Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
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FDA Class 2
·Obstetrics/Gynecology
Ultra-Fast Vitri; Ultra-Fast Warm
FDA 510(k)
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FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Donnevie Medical Technology (Shanghai) Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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]) | Aug 27, 2025 | Substantially Equivalent |
| K231370 | Dewin Blastocyst Medium (with HSA and without HSA) | Aug 4, 2023 | Substantially Equivalent |
| K212426 | Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) | Jun 16, 2022 | Substantially Equivalent |