Cleared Traditional

K801761 - PDS COMPUTER UNIT/VIDEO TERMINAL

K801761 is the FDA 510(k) clearance for PDS COMPUTER UNIT/VIDEO TERMINAL by General Electric Co.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K801761 · General Electric Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1980
Decision
23d
Days
Class 2
Risk

K801761 is an FDA 510(k) clearance for the PDS COMPUTER UNIT/VIDEO TERMINAL. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 23 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 General Electric Co. devices

Submission Details

510(k) Number K801761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 20, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
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 151
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K801761.
CENTRAL STATION MONITOR
K812271 · Datascope Corp. · Aug 1981
RESIDENT BEDSIDE MONITOR
K811216 · Abbott Laboratories · Jul 1981
ADVANCMED ELIMINATOR
K803223 · American Edwards Laboratories · Jan 1981
A-V MINI CLINIC
K800405 · Instromedix, Inc. · Jul 1980
HEART RATE MONITOR MD-1
K792312 · Medical Devices, Inc. · Nov 1979
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979