Cleared Traditional

WISCONSIN HEART RATE MONITOR (K802182) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802182 · Lunar Radiation Corp. · Cardiovascular device
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Oct 1980
Decision
52d
Days
Class 2
Risk

K802182 is an FDA 510(k) clearance for the WISCONSIN HEART RATE MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Lunar Radiation Corp. (Mchenry, US). The FDA issued a Cleared decision on October 31, 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 870.2300 - 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 Lunar Radiation Corp. devices

Submission Details

510(k) Number K802182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1980
Decision Date October 31, 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. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 68
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K802182.
MODEL 2000 MONITOR
K812828 · Datascope Corp. · Nov 1981
CENTRAL STATION MONITOR
K812271 · Datascope Corp. · Aug 1981
RESIDENT BEDSIDE MONITOR
K811216 · Abbott Laboratories · Jul 1981
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · General Electric Co. · Aug 1980
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
ECG MONITORING SYSTEM,
K780404 · Quinton, Inc. · Mar 1978