510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920631Substantially Equivalent

Bioject Jet Injection System

Bioject, Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920631 is the FDA 510(k) clearance record for BIOJECT JET INJECTION SYSTEM, a class II device, cleared for Bioject, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list 9 510(k) clearances for Bioject, Inc., from to . As of , FDA records show no recalls naming K920631.

Clearance record

Decision date
Received
(867 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, Inc. 7620 SW Bridgeport Rd., Portland OR
510(k) summary
Statement
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