510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050434Substantially Equivalent

Shl Disposable Autoinjector

Shl Medical, USA, Florham Park NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050434 is the FDA 510(k) clearance record for SHL DISPOSABLE AUTOINJECTOR, a class II device, cleared for Shl Medical, USA on under FDA product code KZH (Introducer, Syringe Needle). FDA records list 2 510(k) clearances for Shl Medical, USA, from to . As of , FDA records show no recalls naming K050434.

Clearance record

Decision date
Received
(122 days to decision)
Product code
KZH Introducer, Syringe Needle
Regulation
21 CFR 880.6920
Device class
Class II
Review panel
General Hospital
Applicant
Shl Medical, USA 23 Vreeland Rd.,, Florham Park NJ
510(k) summary
Summary PDF
Third party review
No

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