510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013256Substantially Equivalent

Bi-3M Needle-Free Injector System

Felton International, Inc., Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013256 is the FDA 510(k) clearance record for BI-3M NEEDLE-FREE INJECTOR SYSTEM, 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 K013256.

Clearance record

Decision date
Received
(67 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. 8210 Marshall Dr., Lenexa KS
510(k) summary
Summary
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