Cleared Traditional

K122388 - SECA MEDICAL BODY COMPOSTION ANALYZER 514

K122388 is the FDA 510(k) clearance for SECA MEDICAL BODY COMPOSTION ANALYZER 514 by Seca GmbH & Co. KG. It is a Class 2 Gastroenterology & Urology device (product code MNW) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K122388 · Seca GmbH & Co. KG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
269d
Days
Class 2
Risk

K122388 is an FDA 510(k) clearance for the SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Seca GmbH & Co. KG (Washington, US). The FDA issued a Cleared decision on May 2, 2013 after a review of 269 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.

View all Seca GmbH & Co. KG devices

Submission Details

510(k) Number K122388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2012
Decision Date May 02, 2013
Days to Decision 269 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 130d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K122388.
Multi-parameter detector
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WI-FI BODY SCALE
K120896 · Andon Health Co, Ltd. · Jul 2012
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K062043 · Omron Healthcare, Inc. · Nov 2006
HL 188 & HL 189 BODY FAT METER
K043414 · Health & Life Co., Ltd. · Feb 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · Omron Healthcare, Inc. · Jan 2005
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc. · Nov 2001