Cleared Traditional

K242043 - Sperm Freezing Medium

K242043 is an FDA 510(k) clearance for Sperm Freezing Medium, manufactured by Gimbo Medical Technology Shenzhen Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K242043 · Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics & Gynecology device
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Jan 2025
Decision
180d
Days
Class 2
Risk

K242043 is an FDA 510(k) clearance for the Sperm Freezing Medium. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 8, 2025 after a review of 180 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gimbo Medical Technology Shenzhen Co., Ltd. devices

FDA 510(k) Submission Details - K242043

510(k) Number K242043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2024
Decision Date January 08, 2025
Days to Decision 180 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 160d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQL Media, Reproductive

All 167
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K242043.
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
K242561 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Apr 2025
V-GRAD
K241833 · Vitromed GmbH · Mar 2025
CaseMONO™ Culture (CMON)
K242107 · Casebioscience, Inc. · Mar 2025
ARTSMedia Semen Wash Medium
K241095 · Artsmedia Denmark Aps · Dec 2024
ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
K241132 · Artsmedia Denmark Aps · Dec 2024
Giftlife® Single-Step Medium Plus
K242968 · Gimbo Medical Technology Shenzhen Co., Ltd. · Nov 2024