Cleared Traditional

K030441 - SYDNEY IVF BLASTOCYST CRYOPRESERVATION ...

K030441 is the FDA 510(k) clearance for SYDNEY IVF BLASTOCYST CRYOPRESERVATION ... by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K030441 · Cook Ob/Gyn · Obstetrics & Gynecology device
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Aug 2003
Decision
199d
Days
Class 2
Risk

K030441 is an FDA 510(k) clearance for the SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on August 29, 2003 after a review of 199 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. 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. Standard predicate reliance. 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 Ob/Gyn devices

Submission Details

510(k) Number K030441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2003
Decision Date August 29, 2003
Days to Decision 199 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 160d · This submission: 199d
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 121
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K030441.
SYDNEY IVF PVP
K031304 · Cook Urological, Inc. · Mar 2004
EARLY CLEAVAGE MEDIUM (ECM)
K033462 · Irvine Scientific Sales Co., Inc. · Jan 2004
PHENOL RED STOCK SOLUTION
K032887 · Irvine Scientific Sales Co., Inc. · Dec 2003
EMBRYOGLUE
K031015 · Vitrolife Sweden AB · Jun 2003
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K023850 · Cook Ob/Gyn · Jan 2003
SYDNEY IVF HYALURONIDASE
K023353 · Cook Urological, Inc. · Dec 2002