Cleared Traditional

K241454 - Minvitro Vitrification Straw (MVT-VSN s...

K241454 is an FDA 510(k) clearance for Minvitro Vitrification Straw (MVT-VSN s..., manufactured by Guangzhou Hehong Biotech Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K241454 · Guangzhou Hehong Biotech Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
257d
Days
Class 2
Risk

K241454 is an FDA 510(k) clearance for the Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, .... Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Guangzhou Hehong Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 3, 2025 after a review of 257 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - 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 Guangzhou Hehong Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K241454

510(k) Number K241454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2024
Decision Date February 03, 2025
Days to Decision 257 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 160d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQK Device Classification - Class 2, Special Controls

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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 Consultant

Manton Business and Technology Services
Melody Huang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQK Labware, Assisted Reproduction

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