Cleared Traditional

K800243 - D668 & D664 CENTRAL MONITORING SYSTEMS

K800243 is the FDA 510(k) clearance for D668 & D664 CENTRAL MONITORING SYSTEMS by Medtel Pty. , Ltd.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K800243 · Medtel Pty. , Ltd. · Cardiovascular device
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Apr 1980
Decision
65d
Days
Class 2
Risk

K800243 is an FDA 510(k) clearance for the D668 & D664 CENTRAL MONITORING SYSTEMS. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Medtel Pty. , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980 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 Medtel Pty. , Ltd. devices

Submission Details

510(k) Number K800243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1980
Decision Date April 10, 1980
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 92
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K800243.
RESIDENT BEDSIDE MONITOR
K811216 · Abbott Laboratories · Jul 1981
ADVANCMED ELIMINATOR
K803223 · American Edwards Laboratories · Jan 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
MONITOR, CARDIAC, BEDSIDE
K772332 · Telectronics, Inc. · Feb 1978