Cleared Traditional

K832130 - MULTISCRIPTOR EK 36/101 047 02,05

K832130 is an FDA 510(k) clearance for MULTISCRIPTOR EK 36/101 047 02, 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 122-day FDA review.

K832130 · Litton Medical Electronics · Cardiovascular device
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Oct 1983
Decision
122d
Days
Class 2
Risk

K832130 is an FDA 510(k) clearance for the MULTISCRIPTOR EK 36/101 047 02,05. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Litton Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 122 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 - K832130

510(k) Number K832130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1983
Decision Date October 31, 1983
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 335
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K832130.
LME PATIENT MONITOR SMS 151
K832013 · Litton Medical Electronics · Oct 1983
MULTISCRIPTOR EK #403 VARIOUS MODEL
K832014 · Litton Medical Electronics · Oct 1983
MULTISCRIPTOR EK VARIOUS #43
K832015 · Litton Medical Electronics · Oct 1983
SIMPLISCRIPTOR EK 31/101 037 16
K832184 · Litton Medical Electronics · Oct 1983
AS 191 ECG TELEMETRY MODULE
K831429 · Narco Scientific · Oct 1983
PATIENT SELECTOR FUNCTION BLOCK
K832212 · Honeywell, Inc. · Oct 1983