Cleared Traditional

K861067 - PARAGON 420

K861067 is the FDA 510(k) clearance for PARAGON 420 by Life Sensing Instrument Company, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K861067 · Life Sensing Instrument Company, Inc. · Cardiovascular device
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Jun 1986
Decision
77d
Days
Class 2
Risk

K861067 is an FDA 510(k) clearance for the PARAGON 420, CARDIAC MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Life Sensing Instrument Company, Inc. (Tullahoma, US). The FDA issued a Cleared decision on June 5, 1986 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Life Sensing Instrument Company, Inc. devices

Submission Details

510(k) Number K861067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1986
Decision Date June 05, 1986
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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.

Regulatory Peers - DPS Electrocardiograph

All 261
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K861067.
SIEMENS-ELEMA (SICARD-P)
K861851 · Mortara Instrument, Inc. · Aug 1986
SIEMENS SIRECUST MODELS 403P,403-2P & 403N
K855096 · Analogic Corp. · Jul 1986
MODEL 43200A CARDIAC MONITOR
K861992 · Hewlett-Packard Co. · Jun 1986
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · Hewlett-Packard Co. · May 1986
CARDIOFAX ECG-6353
K860212 · Nihon Kohden America, Inc. · Apr 1986
VSM-5
K852322 · Physio-Control Corp. · Sep 1985