Cleared Traditional

K802103 - ECG RECALL & EDIT PRODUCT VERSION-A3601

K802103 is an FDA 510(k) clearance for ECG RECALL & EDIT PRODUCT VERSION-A3601, manufactured by General Electric Co.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K802103 · General Electric Co. · Cardiovascular device
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Sep 1980
Decision
23d
Days
Class 2
Risk

K802103 is an FDA 510(k) clearance for the ECG RECALL & EDIT PRODUCT VERSION-A3601. 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 September 26, 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 870.1025 - 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.

FDA 510(k) Submission Details - K802103

510(k) Number K802103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1980
Decision Date September 26, 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.

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 397
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K802103.
CC101 ECG MONITORING SYSTEM
K802312 · Anthro-Metrics Corp. · Jan 1981
BIOMETRIC ERG SYSTEM
K802472 · Biometric Analysis Group, Inc. · Nov 1980
OXFORD INTENSIVE CARE PATIENT MON. SYS
K802033 · Oxford Medilog, Inc. · Sep 1980
COMPUTER ECG TERMINAL
K802272 · Compumed, Inc. · Sep 1980
EVALUATOR #9500 DYNAMIC ELEC/SCANNER
K801831 · Del Mar Avionics · Sep 1980
MICRO-PROCESSOR UNIT #A3600AC
K801762 · General Electric Co. · Aug 1980
K802103 · ECG RECALL & EDIT PRODUCT VERSION-A3601
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