Cleared Traditional

K820881 - MEMOPORT C

K820881 is the FDA 510(k) clearance for MEMOPORT C by Litton Medical Electronics. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K820881 · Litton Medical Electronics · Cardiovascular device
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May 1982
Decision
49d
Days
Class 2
Risk

K820881 is an FDA 510(k) clearance for the MEMOPORT C. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Litton Medical Electronics (Walker, US). The FDA issued a Cleared decision on May 18, 1982 after a review of 49 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.

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Submission Details

510(k) Number K820881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1982
Decision Date May 18, 1982
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
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 140
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K820881.
WLECTROCARDIOGRAPH ECG-7204
K831274 · Nihon Kohden America, Inc. · Oct 1983
SERIES 7000 BEDSIDE PATIENT MONITOR
K822718 · Marquette Electronics, Inc. · Oct 1982
MULTIPLE LEAD ARRHYTHMIA MODULE
K822030 · Marquette Electronics, Inc. · Sep 1982
QUINTON Q2000 ETT MONITORING SYSTEM
K820438 · Quinton, Inc. · Apr 1982
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477 · Hewlett-Packard Co. · Apr 1982
MICRO-PREPROCESSOR UNIT
K812914 · General Electric Co. · Dec 1981