Cleared Traditional

K930599 - BODY FAT ANALYZER MODEL TBF-105

K930599 is an FDA 510(k) clearance for BODY FAT ANALYZER MODEL TBF-105, manufactured by Tanita Corp. of America. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 634-day FDA review.

K930599 · Tanita Corp. of America · Cardiovascular device
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Nov 1994
Decision
634d
Days
Class 2
Risk

K930599 is an FDA 510(k) clearance for the BODY FAT ANALYZER MODEL TBF-105. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Tanita Corp. of America (Skokie, US). The FDA issued a Cleared decision on November 1, 1994 after a review of 634 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Tanita Corp. of America devices

FDA 510(k) Submission Details - K930599

510(k) Number K930599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1993
Decision Date November 01, 1994
Days to Decision 634 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
509d slower than avg
Panel avg: 125d · This submission: 634d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DSB Plethysmograph, Impedance

All 57
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K930599.
PERCUPUMP II WITH EDA
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BIOZ SYSTEM
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K942227 · C.L. Mcintosh & Assoc., Inc. · Jun 1996
PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM
K896034 · D. E. Hokanson, Inc. · Jan 1990
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS
K881841 · Buckman Co., Inc. · Dec 1988
BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER
K884033 · Biodynamics Corp. · Nov 1988