Cleared Traditional

K150950 - FreezeKit Cleave , ThawKit Cleave

K150950 is an FDA 510(k) clearance for FreezeKit Cleave, manufactured by Vitrolife Sweden AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K150950 · Vitrolife Sweden AB · Obstetrics & Gynecology device
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Dec 2015
Decision
257d
Days
Class 2
Risk

K150950 is an FDA 510(k) clearance for the FreezeKit Cleave , ThawKit Cleave. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Englewood, US). The FDA issued a Cleared decision on December 21, 2015 after a review of 257 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - 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 Vitrolife Sweden AB devices

FDA 510(k) Submission Details - K150950

510(k) Number K150950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2015
Decision Date December 21, 2015
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.

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 213
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K150950.
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SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
K152782 · William A. Cook Australia Pty. , Ltd. · Dec 2015
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K152904 · William A. Cook Australia Pty. , Ltd. · Dec 2015
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K152440 · Willam A. Cook Australia Pty, Ltd. · Sep 2015