Cleared Traditional

HA-2 HUMAN BODY COMPOSITION ANALYZER (K860749) - FDA 510(k) Clearance

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

K860749 · Dj Medical Instrument Corp. C/O Keller & Heckman · Cardiovascular device
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Sep 1986
Decision
187d
Days
Class 2
Risk

K860749 is an FDA 510(k) clearance for the HA-2 HUMAN BODY COMPOSITION ANALYZER. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Dj Medical Instrument Corp. C/O Keller & Heckman (Washington, US). The FDA issued a Cleared decision on September 2, 1986 after a review of 187 days - an extended review cycle.

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 Dj Medical Instrument Corp. C/O Keller & Heckman devices

Submission Details

510(k) Number K860749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1986
Decision Date September 02, 1986
Days to Decision 187 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 125d · This submission: 187d
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.