Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)— 510(k) K242089

Name: FDA 510(k) clearance K242089
Creator: U.S. Food and Drug Administration
Published: 2025-04-10

Substantially Equivalent

Jiangsu Ruifuda Medical Device Co., Ltd.

FDA 510(k) clearance K242089 for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202), Substantially Equivalent on 2025-04-10. Applicant: Jiangsu Ruifuda Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jiangsu Ruifuda Medical Device Co., Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2024-07-17
Decision date: 2025-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lianyungang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQL

view all

K254261 — Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)2026-08-28
K260248 — Ultra-Fast Warm2026-04-28
K252672 — CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)2026-02-20
K250445 — Fast Warm - NX2025-09-12
K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more2025-08-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.