Cleared Traditional

K033101 - G-PGD

K033101 is the FDA 510(k) clearance for G-PGD by Vitrolife Sweden AB. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K033101 · Vitrolife Sweden AB · Obstetrics & Gynecology device
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May 2004
Decision
221d
Days
Class 2
Risk

K033101 is an FDA 510(k) clearance for the G-PGD. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Washington, US). The FDA issued a Cleared decision on May 7, 2004 after a review of 221 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 Sweden AB devices

Submission Details

510(k) Number K033101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date May 07, 2004
Days to Decision 221 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 160d · This submission: 221d
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 121
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K033101.
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ICSI-100
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G-OOCYTE
K032877 · Vitrolife Sweden AB · May 2004
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EARLY CLEAVAGE MEDIUM (ECM)
K033462 · Irvine Scientific Sales Co., Inc. · Jan 2004