Cleared Traditional

K862714 - BILATERAL IMPEDANCE PLETHYSMOGRAPH

K862714 is the FDA 510(k) clearance for BILATERAL IMPEDANCE PLETHYSMOGRAPH by Electro-Diagnostic Instruments. It is a Class 2 Cardiovascular device (product code DSB) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K862714 · Electro-Diagnostic Instruments · Cardiovascular device
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Nov 1986
Decision
124d
Days
Class 2
Risk

K862714 is an FDA 510(k) clearance for the BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM). Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Electro-Diagnostic Instruments (Burbank, US). The FDA issued a Cleared decision on November 17, 1986 after a review of 124 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.

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Submission Details

510(k) Number K862714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1986
Decision Date November 17, 1986
Days to Decision 124 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 125d · This submission: 124d
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.