Cleared Traditional

K830362 - INFANT ELECTRODE BELT

K830362 is the FDA 510(k) clearance for INFANT ELECTRODE BELT by Sentry Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K830362 · Sentry Medical Products, Inc. · Cardiovascular device
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Jun 1983
Decision
120d
Days
Class 2
Risk

K830362 is an FDA 510(k) clearance for the INFANT ELECTRODE BELT. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Sentry Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on June 3, 1983 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 Sentry Medical Products, Inc. devices

Submission Details

510(k) Number K830362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1983
Decision Date June 03, 1983
Days to Decision 120 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 faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 83
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K830362.
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445 · Graphic Controls Corp. · Apr 1984
ADULT MONITORING ELECTOR@@RODE 9431-300
K833695 · Marquette Electronics, Inc. · Jan 1984
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · Quinton, Inc. · Jun 1983
MEDI-TRACE 5' OFFSET ELECTRODE
K822750 · Graphic Controls Corp. · Nov 1982
CENTURION ELECTRODE BELT
K821802 · Clinical Data, Inc. · Jul 1982
QUIK - PREP2 ELECTRODE
K821757 · Quinton, Inc. · Jul 1982