Cleared Traditional

K022247 - G-SPERM

K022247 is the FDA 510(k) clearance for G-SPERM by Vitrolife Sweden AB. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K022247 · Vitrolife Sweden AB · Obstetrics & Gynecology device
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Sep 2002
Decision
56d
Days
Class 2
Risk

K022247 is an FDA 510(k) clearance for the G-SPERM, MODEL 10032. 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 September 6, 2002 after a review of 56 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 Vitrolife Sweden AB devices

Submission Details

510(k) Number K022247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2002
Decision Date September 06, 2002
Days to Decision 56 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
104d faster than avg
Panel avg: 160d · This submission: 56d
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 K022247.
HSA-SOLUTION, MODEL 10034/10064
K021896 · Vitrolife Sweden AB · Sep 2002
G-1 VERSION 3, MODEL 10048
K022244 · Vitrolife Sweden AB · Sep 2002
G-FERT, MODEL 10033
K022245 · Vitrolife Sweden AB · Sep 2002
SYDNEY IVF CULTURE OIL
K022002 · Cook Urological, Inc. · Aug 2002
EMBRYO BIOPSY MEDIUM
K021358 · Irvine Scientific Sales Co., Inc. · Jul 2002
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
K013518 · Irvine Scientific Sales Co., Inc. · Jan 2002