Cleared Traditional

K102516 - LUCINA MODEL MELODI

K102516 is an FDA 510(k) clearance for LUCINA MODEL 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 343-day FDA review.

K102516 · Genadyne Biotechnologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
343d
Days
Class 2
Risk

K102516 is an FDA 510(k) clearance for the LUCINA MODEL MELODI. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Genadyne Biotechnologies, Inc. (Great Neck, US). The FDA issued a Cleared decision on August 11, 2011 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K102516

510(k) Number K102516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2010
Decision Date August 11, 2011
Days to Decision 343 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
182d slower than avg
Panel avg: 161d · This submission: 343d
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 227
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K102516.
LUCINA-MELODI
K112856 · Genadyne Biotechnologies, Inc. · May 2012
CLOSER TO NATURE ELECTRIC BREAST PUMP
K113664 · Mayborn Group Limited · Feb 2012
FREEMIE (R)
K111411 · Dao Health · Feb 2012
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
K110343 · Mayborn Baby and Child / Jackel International, Ltd. · Mar 2011
SIMPLYGO BREAST PUMP
K102600 · Evenflo Company, Inc. · Dec 2010
E-BASIC SINGLE BREAST PUMP
K101157 · Mapa GmbH · Sep 2010