Cleared Traditional

K011157 - COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT

K011157 is an FDA 510(k) clearance for COOK IVF CRYOPRESERVATION KIT AND THE C..., manufactured by Cook Urological, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K011157 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
17d
Days
Class 2
Risk

K011157 is an FDA 510(k) clearance for the COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT. 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 May 3, 2001 after a review of 17 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Urological, Inc. devices

FDA 510(k) Submission Details - K011157

510(k) Number K011157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2001
Decision Date May 03, 2001
Days to Decision 17 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
143d faster than avg
Panel avg: 160d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 188
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K011157.
EMBRYO BIOPSY MEDIUM
K021358 · Irvine Scientific Sales Co., Inc. · Jul 2002
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
K013518 · Irvine Scientific Sales Co., Inc. · Jan 2002
OIL FOR EMBRYO CULTURE
K011938 · Irvine Scientific Sales Co., Inc. · Jul 2001
GLOBAL BY BLASTOCYST MEDIA
K010183 · Intl., Inc. · May 2001
BLASTASSIST SYSTEM
K003156 · Medicult A/S · Mar 2001
SYNVITRO FLUSH
K003163 · Medicult A/S · Mar 2001