Cleared Traditional

K874361 - BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER

K874361 is an FDA 510(k) clearance for BIODYNAMICS MODEL BI-300 BODY COMPOSITI..., manufactured by Biodynamics Corp.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K874361 · Biodynamics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
145d
Days
Class 2
Risk

K874361 is an FDA 510(k) clearance for the BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Biodynamics Corp. (Seattle, US). The FDA issued a Cleared decision on March 16, 1988 after a review of 145 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 Biodynamics Corp. devices

FDA 510(k) Submission Details - K874361

510(k) Number K874361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1987
Decision Date March 16, 1988
Days to Decision 145 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 125d · This submission: 145d
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 25
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K874361.
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS
K881841 · Buckman Co., Inc. · Dec 1988
BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER
K884033 · Biodynamics Corp. · Nov 1988
BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER
K881968 · Biodynamics Corp. · Jul 1988
CARDIAC WALL MOTION DEVICE
K833728 · Intl. Medical, Inc. · Feb 1984