Cleared Traditional

K033462 - EARLY CLEAVAGE MEDIUM (ECM)

K033462 is an FDA 510(k) clearance for EARLY CLEAVAGE MEDIUM (ECM), 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 76-day FDA review.

K033462 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
76d
Days
Class 2
Risk

K033462 is an FDA 510(k) clearance for the EARLY CLEAVAGE MEDIUM (ECM). 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 January 15, 2004 after a review of 76 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 - K033462

510(k) Number K033462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2003
Decision Date January 15, 2004
Days to Decision 76 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
84d faster than avg
Panel avg: 160d · This submission: 76d
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 K033462.
G-PGD
K033101 · Vitrolife Sweden AB · May 2004
MULTIBLAST MEDIUM
K034063 · Irvine Scientific Sales Co., Inc. · Apr 2004
SYDNEY IVF PVP
K031304 · Cook Urological, Inc. · Mar 2004
PHENOL RED STOCK SOLUTION
K032887 · Irvine Scientific Sales Co., Inc. · Dec 2003
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
K030441 · Cook Ob/Gyn · Aug 2003
ISM1+, IMS2+, AND UTM+
K030490 · Medicult A/S · Aug 2003