Cleared Traditional

K011938 - OIL FOR EMBRYO CULTURE

K011938 is an FDA 510(k) clearance for OIL FOR EMBRYO CULTURE, manufactured by Irvine Scientific Sales Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K011938 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
27d
Days
Class 2
Risk

K011938 is an FDA 510(k) clearance for the OIL FOR EMBRYO CULTURE. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 18, 2001 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. 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 Irvine Scientific Sales Co., Inc. devices

FDA 510(k) Submission Details - K011938

510(k) Number K011938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2001
Decision Date July 18, 2001
Days to Decision 27 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
133d faster than avg
Panel avg: 160d · This submission: 27d
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 167
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K011938.
SYDNEY IVF CULTURE OIL
K022002 · Cook Urological, Inc. · Aug 2002
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
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · Cook Urological, Inc. · May 2001
GLOBAL BY BLASTOCYST MEDIA
K010183 · Intl., Inc. · May 2001
BLASTASSIST SYSTEM
K003156 · Medicult A/S · Mar 2001