510(k) Report

FDA applicant

Donnevie Medical Technology (Shanghai) Co., Ltd.

Shanghai, CN4 decisions2022–20250 recalls

FDA records 4 decisions for Donnevie Medical Technology (Shanghai) Co., Ltd. (Shanghai, CN) from 2022 to 2025: 4 510(k) clearances. All are in product code MQL (Media, Reproductive). Since 2016 its 510(k)s took a median of 158 days from receipt to decision, against 225 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Donnevie Medical Technology (Shanghai) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2022: 12023: 12025: 2
2022high 2 (2025) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Donnevie Medical Technology (Shanghai) Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQLMedia, Reproductive4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 158 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 225 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025
  • K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025
  • K231370Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd. · 2023
  • K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2022

All 4 as Donnevie Medical Technology (Shanghai) Co., Ltd. →