510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141384Substantially Equivalent

Whisperject Autoinjector

Scandinavian Health Ltd., Deerfield Beach FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141384 is the FDA 510(k) clearance record for WHISPERJECT AUTOINJECTOR, a class II device, cleared for Scandinavian Health Limited on under FDA product code KZH (Introducer, Syringe Needle). FDA records list 4 510(k) clearances for Scandinavian Health Limited, from to . As of , FDA records show no recalls naming K141384.

Clearance record

Decision date
Received
(108 days to decision)
Product code
KZH Introducer, Syringe Needle
Regulation
21 CFR 880.6920
Device class
Class II
Review panel
General Hospital
Applicant
Scandinavian Health Limited #588 Jim Moran Blvd., Deerfield Beach FL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code KZH

Trailing 12 months

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

FDA records show no clearances under product code KZH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZH, 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