Cleared Traditional

ANDRIES PHYSICAL ASSESSMENT COMPUTER (K870545) - FDA 510(k) Clearance

Class I Cardiovascular device.

K870545 · Andries Tek, Inc. · Cardiovascular device
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Aug 1987
Decision
185d
Days
Class 1
Risk

K870545 is an FDA 510(k) clearance for the ANDRIES PHYSICAL ASSESSMENT COMPUTER. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Andries Tek, Inc. (Austin, US). The FDA issued a Cleared decision on August 14, 1987 after a review of 185 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2390 - 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 Andries Tek, Inc. devices

Submission Details

510(k) Number K870545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1987
Decision Date August 14, 1987
Days to Decision 185 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQC Phonocardiograph
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.