Cleared Traditional

K112856 - LUCINA-MELODI

K112856 is an FDA 510(k) clearance for LUCINA-MELODI, manufactured by Genadyne Biotechnologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K112856 · Genadyne Biotechnologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
223d
Days
Class 2
Risk

K112856 is an FDA 510(k) clearance for the LUCINA-MELODI. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Genadyne Biotechnologies, Inc. (Hicksville, US). The FDA issued a Cleared decision on May 10, 2012 after a review of 223 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - 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 Genadyne Biotechnologies, Inc. devices

FDA 510(k) Submission Details - K112856

510(k) Number K112856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date May 10, 2012
Days to Decision 223 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
63d slower than avg
Panel avg: 160d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGX Device Classification - Class 2, Special Controls

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
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 - HGX Pump, Breast, Powered

All 136
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