510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041280Substantially Equivalent

Human Subcutaneous Injector, Model Hsi 500

Felton International, Inc., Lee'S Summit MO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041280 is the FDA 510(k) clearance record for HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500, a class II device, cleared for Felton International, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list 2 510(k) clearances for Felton International, Inc., from to . As of , FDA records show no recalls naming K041280.

Clearance record

Decision date
Received
(42 days to decision)
Product code
KZE Injector, Fluid, Non-Electrically Powered
Regulation
21 CFR 880.5430
Device class
Class II
Review panel
General Hospital
Applicant
Felton International, Inc. 200 NE Mulberry, Suite 200, Lee'S Summit MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KZE

Trailing 12 months

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

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