Cleared Traditional

K022247 - G-SPERM, MODEL 10032

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

K022247 · Vitrolife Sweden AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K022247

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.

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 213
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K022247.
HSA-SOLUTION, MODEL 10034/10064
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K022244 · Vitrolife Sweden AB · Sep 2002
G-FERT, MODEL 10033
K022245 · Vitrolife Sweden AB · Sep 2002
PVP (POLYVINYLPYRROLIDONE)
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HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS
K022334 · Intl., Inc. · Aug 2002
HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
K022352 · Intl., Inc. · Aug 2002