Cleared Special

K152440 - Sydney IVF PVP

K152440 is an FDA 510(k) clearance for Sydney IVF PVP, manufactured by Willam 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 27-day FDA review.

K152440 · Willam 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
Sep 2015
Decision
27d
Days
Class 2
Risk

K152440 is an FDA 510(k) clearance for the Sydney IVF PVP. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Willam A. Cook Australia Pty, Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on September 23, 2015 after a review of 27 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 - K152440

510(k) Number K152440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date September 23, 2015
Days to Decision 27 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
134d faster than avg
Panel avg: 161d · This submission: 27d
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
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