Cleared Traditional

THE HEART PROTECTOR (K944481) - FDA 510(k) Clearance

Class I General Hospital device.

K944481 · Garan Scientific, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
209d
Days
Class 1
Risk

K944481 is an FDA 510(k) clearance for the THE HEART PROTECTOR. Classified as Dispenser, Solid Medication (product code NXB), Class I - General Controls.

Submitted by Garan Scientific, Inc. (Morristown, US). The FDA issued a Cleared decision on April 10, 1995 after a review of 209 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5050 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Garan Scientific, Inc. devices

Submission Details

510(k) Number K944481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1994
Decision Date April 10, 1995
Days to Decision 209 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 129d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NXB Dispenser, Solid Medication
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
Definition A Solid Medication Dispenser Is A Device Intended For Medical Purposes That Is Used To Issue Solid (pills) Medication.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.