Cleared Special

K143724 - COOK Sydney IVF Blastocyst Vitrificatio...

K143724 is an FDA 510(k) clearance for COOK Sydney IVF Blastocyst Vitrificatio..., manufactured by William A. Cook Australia Pty. , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Special 510(k) pathway after a 241-day FDA review.

K143724 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
241d
Days
Class 2
Risk

K143724 is an FDA 510(k) clearance for the COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warm.... Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by William A. Cook Australia Pty. , Ltd. (Brisbane, AU). The FDA issued a Cleared decision on August 27, 2015 after a review of 241 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all William A. Cook Australia Pty. , Ltd. devices

FDA 510(k) Submission Details - K143724

510(k) Number K143724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date August 27, 2015
Days to Decision 241 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 160d · This submission: 241d
Pathway characteristics
Modification to existing cleared device.

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 168
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