Cleared Special

K152904 - SYDNEY IVF EMBRYO BIOPSY MEDIUM

K152904 is an FDA 510(k) clearance for SYDNEY IVF EMBRYO BIOPSY MEDIUM, 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 63-day FDA review.

K152904 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
63d
Days
Class 2
Risk

K152904 is an FDA 510(k) clearance for the SYDNEY IVF EMBRYO BIOPSY MEDIUM. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on December 3, 2015 after a review of 63 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K152904

510(k) Number K152904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2015
Decision Date December 03, 2015
Days to Decision 63 days
Submission Type Special
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
98d faster than avg
Panel avg: 161d · This submission: 63d
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 259
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K152904.
Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium
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Sydney IVF PVP
K152440 · Willam A. Cook Australia Pty, Ltd. · Sep 2015
COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
K143724 · William A. Cook Australia Pty. , Ltd. · Aug 2015
LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
K142991 · Life Global Group, LLC · Feb 2015