Cleared Traditional

K832015 - MULTISCRIPTOR EK VARIOUS #43

K832015 is the FDA 510(k) clearance for MULTISCRIPTOR EK VARIOUS #43 by Litton Medical Electronics. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K832015 · Litton Medical Electronics · Cardiovascular device
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Oct 1983
Decision
130d
Days
Class 2
Risk

K832015 is an FDA 510(k) clearance for the MULTISCRIPTOR EK VARIOUS #43. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Litton Medical Electronics (Walker, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Litton Medical Electronics devices

Submission Details

510(k) Number K832015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date October 31, 1983
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 177
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K832015.
VITAL SIGNS MONITOR 3
K833584 · Physio-Control Corp. · Jan 1984
CASE-II
K833458 · Marquette Electronics, Inc. · Nov 1983
PACEMAKER EVALUATION MODULE-330
K833470 · Marquette Electronics, Inc. · Nov 1983
PATIENT SELECTOR FUNCTION BLOCK
K832212 · Honeywell, Inc. · Oct 1983
CONVERTER UNIT FOR ECG TRACE DISPLAY
K830566 · Honeywell, Inc. · May 1983
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · Nihon Kohden America, Inc. · Dec 1982