Cleared Traditional

K900321 - DYNATRON 330 BODY COMPOSITION ANALYZER

K900321 is an FDA 510(k) clearance for DYNATRON 330 BODY COMPOSITION ANALYZER, manufactured by Dynatronics Laser Corp.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K900321 · Dynatronics Laser Corp. · Cardiovascular device
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Jun 1990
Decision
139d
Days
Class 2
Risk

K900321 is an FDA 510(k) clearance for the DYNATRON 330 BODY COMPOSITION ANALYZER. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Dynatronics Laser Corp. (Salt Lake City, US). The FDA issued a Cleared decision on June 11, 1990 after a review of 139 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Dynatronics Laser Corp. devices

FDA 510(k) Submission Details - K900321

510(k) Number K900321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1990
Decision Date June 11, 1990
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
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 52
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K900321.
PERCUPUMP II WITH EDA
K961845 · E-Z-Em, Inc. · Jan 1997
BIOZ SYSTEM
K963183 · Cardiodynamics International Corp. · Nov 1996
NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM
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