Cleared Traditional

K883103 - EPICARDIA PC/FC

K883103 is an FDA 510(k) clearance for EPICARDIA PC/FC, manufactured by Medicomp, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K883103 · Medicomp, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
62d
Days
Class 2
Risk

K883103 is an FDA 510(k) clearance for the EPICARDIA PC/FC. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Medicomp, Inc. (West Melbourne, US). The FDA issued a Cleared decision on September 22, 1988 after a review of 62 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 Medicomp, Inc. devices

FDA 510(k) Submission Details - K883103

510(k) Number K883103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1988
Decision Date September 22, 1988
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
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 243
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K883103.
MODEL 499 SSR ANALYSIS SYSTEM
K884887 · Del Mar Avionics · Feb 1989
E550 ELECTROCARDIOGRAPH
K883440 · Burdick Corp. · Jan 1989
Q4000 OPTION FOR Q4000
K882978 · Quinton, Inc. · Nov 1988
HORIZON 2000 ARRHYTHMIA MONITORING OPTION
K881273 · Mennen Medical, Inc. · Jul 1988
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
K880664 · Mortara Instrument, Inc. · Mar 1988
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
K870816 · Kontron Instruments, Inc. · Mar 1988