Cleared Traditional

K031304 - SYDNEY IVF PVP

K031304 is the FDA 510(k) clearance for SYDNEY IVF PVP by Cook Urological, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K031304 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
334d
Days
Class 2
Risk

K031304 is an FDA 510(k) clearance for the SYDNEY IVF PVP. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on March 23, 2004 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K031304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date March 23, 2004
Days to Decision 334 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
174d slower than avg
Panel avg: 160d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 55
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K031304.
ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)
K173624 · Origio A/S · Mar 2018
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
SYDNEY IVF HYALURONIDASE
K023353 · Cook Urological, Inc. · Dec 2002
SYDNEY IVF CULTURE OIL
K022002 · Cook Urological, Inc. · Aug 2002
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · Cook Urological, Inc. · May 2001