Cleared Traditional

K832015 - MULTISCRIPTOR EK VARIOUS #43

K832015 is an FDA 510(k) clearance for MULTISCRIPTOR EK VARIOUS #43, manufactured by Litton Medical Electronics. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K832015

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
Combination Product No
PCCP Authorized No
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.

DPS Device Classification - Class 2, Special Controls

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 330
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K832015.
PACEMAKER EVALUATION MODULE-330
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K832014 · Litton Medical Electronics · Oct 1983
MULTISCRIPTOR EK 36/101 047 02,05
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SIMPLISCRIPTOR EK 31/101 037 16
K832184 · Litton Medical Electronics · Oct 1983
AS 191 ECG TELEMETRY MODULE
K831429 · Narco Scientific · Oct 1983