Cleared Traditional

K081587 - KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530

K081587 is an FDA 510(k) clearance for KRELL WEIGHT & BODY FAT MONITORING SCALE, manufactured by Krell Precision (Yang Zhou) Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K081587 · Krell Precision (Yang Zhou) Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 2008
Decision
141d
Days
Class 2
Risk

K081587 is an FDA 510(k) clearance for the KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Krell Precision (Yang Zhou) Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on October 24, 2008 after a review of 141 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 Krell Precision (Yang Zhou) Co., Ltd. devices

FDA 510(k) Submission Details - K081587

510(k) Number K081587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2008
Decision Date October 24, 2008
Days to Decision 141 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
10d slower than avg
Panel avg: 131d · This submission: 141d
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 K081587.
TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
K090479 · Tanita Corporation of America · Jul 2009
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
K083838 · Fook Tin Technologies Limited · May 2009
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
K082253 · Bodystat , Ltd. · Nov 2008
OHMNISCAN NG
K073334 · Christine Valmy, Inc. · Aug 2008
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
K073227 · Aiia Communication, Inc. · Mar 2008
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
K072325 · Jawon Medical Co., Ltd. · Nov 2007