Cleared Traditional

K032887 - PHENOL RED STOCK SOLUTION

K032887 is an FDA 510(k) clearance for PHENOL RED STOCK SOLUTION, 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 94-day FDA review.

K032887 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
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Dec 2003
Decision
94d
Days
Class 2
Risk

K032887 is an FDA 510(k) clearance for the PHENOL RED STOCK SOLUTION. 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 December 19, 2003 after a review of 94 days - within the typical 510(k) review window.

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 Irvine Scientific Sales Co., Inc. devices

FDA 510(k) Submission Details - K032887

510(k) Number K032887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2003
Decision Date December 19, 2003
Days to Decision 94 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
66d faster than avg
Panel avg: 160d · This submission: 94d
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 K032887.
MULTIBLAST MEDIUM
K034063 · Irvine Scientific Sales Co., Inc. · Apr 2004
SYDNEY IVF PVP
K031304 · Cook Urological, Inc. · Mar 2004
EARLY CLEAVAGE MEDIUM (ECM)
K033462 · Irvine Scientific Sales Co., Inc. · Jan 2004
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
BLASTFREEZE AND BLASTTHAW
K031486 · Medicult A/S · Jun 2003