Cleared Traditional

K980971 - BODYSTAT DUALSCAN 2005

K980971 is an FDA 510(k) clearance for BODYSTAT DUALSCAN 2005, manufactured by Bodystat , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K980971 · Bodystat , Ltd. · Gastroenterology & Urology device
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Jun 1998
Decision
87d
Days
Class 2
Risk

K980971 is an FDA 510(k) clearance for the BODYSTAT DUALSCAN 2005. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Bodystat , Ltd. (British Isles, BR). The FDA issued a Cleared decision on June 11, 1998 after a review of 87 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.

View all Bodystat , Ltd. devices

FDA 510(k) Submission Details - K980971

510(k) Number K980971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1998
Decision Date June 11, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 131d · This submission: 87d
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 K980971.
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc. · Nov 2001
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K994242 · Bodystat , Ltd. · Mar 2000
FUTREX-6100/XL
K963271 · Futrex, Inc. · Aug 1998
BODYSTAT
K971554 · Bodystat , Ltd. · Nov 1997
HBF-1000 OMRON BODY COMPOSITION ANALYZER
K963575 · Omron Healthcare, Inc. · Jun 1997