Cleared Traditional

MODEL 8300 TESTER (K823197) - FDA 510(k) Clearance

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

K823197 · Medicon, Inc. · Cardiovascular device
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Dec 1982
Decision
65d
Days
Class 2
Risk

K823197 is an FDA 510(k) clearance for the MODEL 8300 TESTER. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Medicon, Inc. (Walker, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 65 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 Medicon, Inc. devices

Submission Details

510(k) Number K823197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date December 30, 1982
Days to Decision 65 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 faster than avg
Panel avg: 125d · This submission: 65d
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 K823197.
PATIENT MONITOR #78832A
K831944 · Hewlett-Packard Co. · Oct 1983
PATIENT MONITOR #78353A
K831787 · Hewlett-Packard Co. · Sep 1983
MODEL 515 NEO-TRAK NEONATAL MONITOR
K823904 · Ge Medical Systems Information Technologies · May 1983
NEUROMEDICS PACETRON HEART RATE MONITOR
K823290 · Intermedics, Inc. · Dec 1982
MODEL 78534A PATIENT MONITOR
K822876 · Hewlett-Packard Co. · Oct 1982
SIGNAL DISTRIBUTION NETWORK #78581A
K822695 · Hewlett-Packard Co. · Oct 1982