Cleared Traditional

K031582 - WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20

K031582 is an FDA 510(k) clearance for WRIST BLOOD PRESSURE MONITOR & FAT METER, manufactured by Nihon Seimitsu Sokki Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K031582 · Nihon Seimitsu Sokki Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
72d
Days
Class 2
Risk

K031582 is an FDA 510(k) clearance for the WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Nihon Seimitsu Sokki Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on August 1, 2003 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K031582

510(k) Number K031582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2003
Decision Date August 01, 2003
Days to Decision 72 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
59d faster than avg
Panel avg: 131d · This submission: 72d
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 K031582.
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
K033157 · Tanita Corp. of America · Apr 2004
HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
K031167 · Idt Technology Limited · Jan 2004
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
K023429 · Rowenta, Inc. · Sep 2003
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
K023817 · Clio Designs, Inc. · Jun 2003
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K020738 · Avita Corporation · May 2003
INBODY AP1 BODY COMPOSITION ANALYZER
K023478 · Biospace Co.,Ltd · May 2003
K031582 · WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
Download PDF FDA Summary Nihon Seimitsu Sokki …