Cleared Traditional

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)

K242089 · Jiangsu Ruifuda Medical Device Co., Ltd. · Obstetrics & Gynecology

Apr 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K242089 is an FDA 510(k) clearance for the Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202), a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Jiangsu Ruifuda Medical Device Co., Ltd. (Lianyungang, CN). The FDA issued a Cleared decision on April 10, 2025, 267 days after receiving the submission on July 17, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number	K242089 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 2024
Decision Date	April 10, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF