Cleared Traditional

K032155 - G-THAWKIT BLAST

K032155 is an FDA 510(k) clearance for G-THAWKIT BLAST, manufactured by Vitrolife AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K032155 · Vitrolife AB · Obstetrics & Gynecology device
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May 2004
Decision
298d
Days
Class 2
Risk

K032155 is an FDA 510(k) clearance for the G-THAWKIT BLAST. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitrolife AB (Washington, US). The FDA issued a Cleared decision on May 7, 2004 after a review of 298 days - an extended review 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: 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 Vitrolife AB devices

FDA 510(k) Submission Details - K032155

510(k) Number K032155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2003
Decision Date May 07, 2004
Days to Decision 298 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
138d slower than avg
Panel avg: 160d · This submission: 298d
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 142
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K032155.
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
K060168 · Irvine Scientific Sales Co., Inc. · Apr 2006
ICSI-100
K043116 · Vitrolife Sweden AB · Jan 2005
MEDIA CULTURE SYSTEM
K040530 · Intl., Inc. · Jun 2004
G-OOCYTE
K032877 · Vitrolife Sweden AB · May 2004
G-PGD
K033101 · Vitrolife Sweden AB · May 2004
MULTIBLAST MEDIUM
K034063 · Irvine Scientific Sales Co., Inc. · Apr 2004