Cleared Traditional

K180073 - Vitavitro Vitrification Kit

K180073 is the FDA 510(k) clearance for Vitavitro Vitrification Kit by Shenzhen Vitavitro Bio-Tech Co., Ltd.. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K180073 · Shenzhen Vitavitro Bio-Tech Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 2018
Decision
232d
Days
Class 2
Risk

K180073 is an FDA 510(k) clearance for the Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Shenzhen Vitavitro Bio-Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 29, 2018 after a review of 232 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 Shenzhen Vitavitro Bio-Tech Co., Ltd. devices

Submission Details

510(k) Number K180073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2018
Decision Date August 29, 2018
Days to Decision 232 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
72d slower than avg
Panel avg: 160d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Field Fu

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 - MQL Media, Reproductive

All 121
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K180073.
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SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
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