Cleared Traditional

K051589 - SLIMMANAGER, MODEL SM-X, SM-E

K051589 is an FDA 510(k) clearance for SLIMMANAGER, manufactured by Aiia Communication, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K051589 · Aiia Communication, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
138d
Days
Class 2
Risk

K051589 is an FDA 510(k) clearance for the SLIMMANAGER, MODEL SM-X, SM-E. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Aiia Communication, Inc. (Deer Field, US). The FDA issued a Cleared decision on October 31, 2005 after a review of 138 days - within the typical 510(k) review window.

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 Aiia Communication, Inc. devices

FDA 510(k) Submission Details - K051589

510(k) Number K051589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2005
Decision Date October 31, 2005
Days to Decision 138 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
7d slower than avg
Panel avg: 131d · This submission: 138d
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 65
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K051589.
AQ-830 SLIM BODY, BODY FAT MONITOR
K052678 · Limax Electronics Co., Ltd. · Dec 2005
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
K052646 · Biospace Corporation Limited · Dec 2005
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
K052522 · Stayhealthy, Inc. · Dec 2005
IMPEDIMED - BODY COMPOSITION ANALYSIS
K050395 · Impedimed Pty , Ltd. · Jul 2005
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