Cleared Traditional

MICRO-PREPROCESSOR UNIT (K812914) - FDA 510(k) Clearance

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

K812914 · General Electric Co. · Cardiovascular device
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Dec 1981
Decision
71d
Days
Class 2
Risk

K812914 is an FDA 510(k) clearance for the MICRO-PREPROCESSOR UNIT. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 71 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 General Electric Co. devices

Submission Details

510(k) Number K812914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1981
Decision Date December 29, 1981
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 67
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K812914.
PEDIATRIC DIAG. CRITERIA OPTION 5600C
K841416 · Hewlett-Packard Co. · Oct 1984
LEAP FROG
K834211 · Philips Medical Systems (Cleveland), Inc. · Jun 1984
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477 · Hewlett-Packard Co. · Apr 1982
GUARDIAN MONITOR (CARDIOVASCULAR)
K803282 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1981
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103 · General Electric Co. · Sep 1980
MICRO-PROCESSOR UNIT #A3600AC
K801762 · General Electric Co. · Aug 1980