Cleared Traditional

K191063 - 1-Step Culture Medium

K191063 is an FDA 510(k) clearance for 1-Step Culture Medium, manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K191063 · Shenzhen Vitavitro Biotech Co., Ltd. · Obstetrics & Gynecology device
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Aug 2019
Decision
123d
Days
Class 2
Risk

K191063 is an FDA 510(k) clearance for the 1-Step Culture Medium. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Shenzhen Vitavitro Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 23, 2019 after a review of 123 days - within the typical 510(k) review window.

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 Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K191063

510(k) Number K191063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2019
Decision Date August 23, 2019
Days to Decision 123 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
37d faster than avg
Panel avg: 160d · This submission: 123d
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.

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All 167
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