Cleared Traditional

BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) (K851415) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851415 · Medi-Sport Testing, Inc. · Cardiovascular device
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Jul 1985
Decision
90d
Days
Class 2
Risk

K851415 is an FDA 510(k) clearance for the BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18). Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Medi-Sport Testing, Inc. (Portland, US). The FDA issued a Cleared decision on July 8, 1985 after a review of 90 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 Medi-Sport Testing, Inc. devices

Submission Details

510(k) Number K851415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date July 08, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.