510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121270Substantially Equivalent

Bioject Needle-Free Injection Management System

Bioject Medical Technologies, Inc., Tigard OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121270 is the FDA 510(k) clearance record for BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM, a class II device, cleared for Bioject Medical Technologies, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list 3 510(k) clearances for Bioject Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K121270.

Clearance record

Decision date
Received
(84 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
Bioject Medical Technologies, Inc. 7180 SW Sandburg St., Suite 100, Tigard OR
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