Cleared Traditional

EARLY CLEAVAGE MEDIUM (ECM) (K033462) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 56
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K033462.
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 PVP
K031304 · Cook Urological, Inc. · Mar 2004
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