Cleared Traditional

K092578 - LIFEGLOBAL PROTEIN SUPPLEMENT

K092578 is an FDA 510(k) clearance for LIFEGLOBAL PROTEIN SUPPLEMENT, manufactured by Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K092578 · Intl., Inc. · Obstetrics & Gynecology device
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Apr 2010
Decision
227d
Days
Class 2
Risk

K092578 is an FDA 510(k) clearance for the LIFEGLOBAL PROTEIN SUPPLEMENT. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Gilford, US). The FDA issued a Cleared decision on April 5, 2010 after a review of 227 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.

FDA 510(k) Submission Details - K092578

510(k) Number K092578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2009
Decision Date April 05, 2010
Days to Decision 227 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 161d · This submission: 227d
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 259
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K092578 · LIFEGLOBAL PROTEIN SUPPLEMENT
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