510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050734Substantially Equivalent

Cool.click

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

K050734 is the FDA 510(k) clearance record for COOL.CLICK, 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 K050734.

Clearance record

Decision date
Received
(74 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. 20245 SW 95th Ave., Tualatin 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