Cleared Traditional

K133872 - ARIA WIFI SMART SCALE

K133872 is an FDA 510(k) clearance for ARIA WIFI SMART SCALE, manufactured by Fitbit, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K133872 · Fitbit, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
164d
Days
Class 2
Risk

K133872 is an FDA 510(k) clearance for the ARIA WIFI SMART SCALE. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Fitbit, Inc. (Fairfax, US). The FDA issued a Cleared decision on June 2, 2014 after a review of 164 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 Fitbit, Inc. devices

FDA 510(k) Submission Details - K133872

510(k) Number K133872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2013
Decision Date June 02, 2014
Days to Decision 164 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
33d slower than avg
Panel avg: 131d · This submission: 164d
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 76
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K133872.
Multi-parameter detector
K231116 · Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. · Jun 2024
BODY COMPOSITION ANALYZER
K140045 · Jawon Medical Co., Ltd. · Feb 2015
BIOSPACE BODY COMPOSITION ANALYZER
K141483 · Biospace Corporation Limited · Sep 2014
BODY FAT ANALYZER AND SCALE
K140594 · Conmo Electronic Company Limited · May 2014
INBODY
K130777 · Biospace Corporation Limited · Nov 2013
BIA / VITALITY ANALYZER
K130856 · Ipgdx, LLC · Nov 2013