Cleared Special

SYDNEY IVF EMBRYO BIOPSY MEDIUM (K152904) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K152904 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (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.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 160d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 Peers - MQL Media, Reproductive

All 56
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K152904.
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
K180073 · Shenzhen Vitavitro Bio-Tech Co., Ltd. · Aug 2018
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SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
K173731 · CooperSurgical, Inc. · Mar 2018
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371 · Cook Urological, Inc. · Aug 2006
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K031304 · Cook Urological, Inc. · Mar 2004
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K023353 · Cook Urological, Inc. · Dec 2002