Cleared Traditional

K802184 - HS10 PORTABLE OPERATING ROOM MONITOR

K802184 is the FDA 510(k) clearance for HS10 PORTABLE OPERATING ROOM MONITOR by Medtel Pty. , Ltd.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K802184 · Medtel Pty. , Ltd. · Cardiovascular device
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Sep 1980
Decision
16d
Days
Class 2
Risk

K802184 is an FDA 510(k) clearance for the HS10 PORTABLE OPERATING ROOM MONITOR. 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 September 26, 1980 after a review of 16 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 K802184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1980
Decision Date September 26, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
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 K802184.
CENTRAL STATION MONITOR
K812271 · Datascope Corp. · Aug 1981
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