Cleared Traditional

K791632 - COMPU-SCAN

K791632 is an FDA 510(k) clearance for COMPU-SCAN, manufactured by Hittman Medical Systems. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K791632 · Hittman Medical Systems · Cardiovascular device
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Nov 1979
Decision
84d
Days
Class 2
Risk

K791632 is an FDA 510(k) clearance for the COMPU-SCAN. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Hittman Medical Systems (Walker, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Hittman Medical Systems devices

FDA 510(k) Submission Details - K791632

510(k) Number K791632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date November 13, 1979
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 315
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K791632.
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103 · General Electric Co. · Sep 1980
EVALUATOR #9500 DYNAMIC ELEC/SCANNER
K801831 · Del Mar Avionics · Sep 1980
MICRO-PROCESSOR UNIT #A3600AC
K801762 · General Electric Co. · Aug 1980
SPECTRA CENTRAL PT MONITORING SYS
K792081 · American Optical Corp. · Nov 1979
DCG-VII ELECTROCARDIOSCANNER
K791424 · Del Mar Avionics · Aug 1979
MODEL 78520A ARRHYTHMIA MONITORING SYS
K791487 · Hewlett-Packard Co. · Aug 1979