Cleared Traditional

K944481 - THE HEART PROTECTOR

K944481 is an FDA 510(k) clearance for THE HEART PROTECTOR, manufactured by Garan Scientific, Inc.. The device is a Class 1 General Hospital device with product code NXB cleared through the Traditional 510(k) pathway after a 209-day FDA review.

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

FDA 510(k) Submission Details - K944481

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.

NXB Device Classification - Class 1, General Controls

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.