Cleared Traditional

K792466 - NIC-200 VENTRICULAR FUNCTION ANALYZER

K792466 is the FDA 510(k) clearance for NIC-200 VENTRICULAR FUNCTION ANALYZER by Nicolet Biomedical Instruments. It is a Class 1 Cardiovascular device (product code DQC) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K792466 · Nicolet Biomedical Instruments · Cardiovascular device
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Jan 1980
Decision
52d
Days
Class 1
Risk

K792466 is an FDA 510(k) clearance for the NIC-200 VENTRICULAR FUNCTION ANALYZER. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Nicolet Biomedical Instruments (Mchenry, US). The FDA issued a Cleared decision on January 24, 1980 after a review of 52 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nicolet Biomedical Instruments devices

Submission Details

510(k) Number K792466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1979
Decision Date January 24, 1980
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
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 K792466.
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