Cleared Traditional

INFANT LIMB ELECTRODE (K844632) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844632 · Sentry Medical Products, Inc. · Cardiovascular device
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Jan 1985
Decision
48d
Days
Class 2
Risk

K844632 is an FDA 510(k) clearance for the INFANT LIMB ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Sentry Medical Products, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 48 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sentry Medical Products, Inc. devices

Submission Details

510(k) Number K844632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date January 14, 1985
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
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 19
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K844632.
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
K874424 · Hewlett-Packard Co. · Jan 1988
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868 · Hewlett-Packard Co. · Jan 1987
CANMED 102
K844099 · Medtronic Vascular · Dec 1984
CANMED 101
K844100 · Medtronic Vascular · Dec 1984
RED DOT MONITORING ELECTRODES #2260/65
K821438 · 3M Company · May 1982