510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944481Substantially Equivalent

The Heart Protector

Garan Scientific, Inc., Morristown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944481 is the FDA 510(k) clearance record for THE HEART PROTECTOR, a class I device, cleared for Garan Scientific, Inc. on under FDA product code NXB (Dispenser, Solid Medication). FDA's definition for product code NXB reads: "A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication". FDA records list one 510(k) clearance for Garan Scientific, Inc. As of , FDA records show no recalls naming K944481.

Clearance record

Decision date
Received
(209 days to decision)
Product code
NXB Dispenser, Solid Medication
Regulation
21 CFR 890.5050
Device class
Class I
Review panel
Physical Medicine
Applicant
Garan Scientific, Inc. P.O. Box 1396, Morristown NJ
510(k) summary
Summary
Third party review
No

Clearances, product code NXB

Trailing 12 months

FDA records hold no clearances under product code NXB in the trailing twelve months.

FDA records show no clearances under product code NXB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NXB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260