Cleared Traditional

K832679 - NON-INVASIVE CLINICAL VASCULAR LAB

K832679 is the FDA 510(k) clearance for NON-INVASIVE CLINICAL VASCULAR LAB by Life Sciences Manufacturing, Inc.. It is a Class 1 Cardiovascular device (product code DQC) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K832679 · Life Sciences Manufacturing, Inc. · Cardiovascular device
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Jan 1984
Decision
147d
Days
Class 1
Risk

K832679 is an FDA 510(k) clearance for the NON-INVASIVE CLINICAL VASCULAR LAB. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Life Sciences Manufacturing, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 147 days - within the typical 510(k) review window.

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 Life Sciences Manufacturing, Inc. devices

Submission Details

510(k) Number K832679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1983
Decision Date January 03, 1984
Days to Decision 147 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 125d · This submission: 147d
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.

Regulatory Peers - DQC Phonocardiograph

Devices cleared under the same product code (DQC) and FDA review panel - the closest regulatory comparables to K832679.
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE
K900560 · Acuson Corp. · Dec 1990
MEDDARS/ULTRA IMAGER PULSE/PHON MODULE
K811626 · Honeywell, Inc. · Jul 1981
AMPLIFIER, PC-700
K780116 · Burdick Corp. · Feb 1978
PULSE/PHONOCARDIOGRAPHY CHANNEL, 144
K770757 · Honeywell, Inc. · May 1977
PHON/STRESS SYSTEM (#21126A)
K760464 · Hewlett-Packard Co. · Aug 1976