Cleared Traditional

K103026 - ELECTRO SENSOR -BODY COMPOSITION

K103026 is an FDA 510(k) clearance for ELECTRO SENSOR -BODY COMPOSITION, manufactured by Ld Technology, LLC. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K103026 · Ld Technology, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
168d
Days
Class 2
Risk

K103026 is an FDA 510(k) clearance for the ELECTRO SENSOR -BODY COMPOSITION. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Ld Technology, LLC (Miami, US). The FDA issued a Cleared decision on March 29, 2011 after a review of 168 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K103026

510(k) Number K103026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2010
Decision Date March 29, 2011
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 131d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNW Device Classification - Class 2, Special Controls

Product Code MNW Analyzer, Body Composition
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MNW Analyzer, Body Composition

All 78
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K103026.
BODY ANALYSIS SCALE, MODEL BG 17
K110928 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Jul 2011
TRANSTEK GLASS BODY ANALYZER
K102191 · Zhongshan Transtek Electronics Co., Ltd. · May 2011
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
K100183 · Tanita Corp. · Apr 2011
MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K082254 · Bodystat , Ltd. · Feb 2011
QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
K082255 · Bodystat , Ltd. · Feb 2011
STAYHEALTHY BODY COMPOSITION MONITOR-BCM
K101807 · Stayhealthy, Inc. · Jan 2011
K103026 · ELECTRO SENSOR -BODY COMPOSITION
Download PDF FDA Summary Ld Technology, LLC