510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142149Substantially Equivalent

Oxytote Infinity Series Vipr Systems

Western Enterprises, Inc., Westlake OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142149 is the FDA 510(k) clearance record for OXYTOTE INFINITY SERIES VIPR SYSTEMS, a class I device, cleared for Western/Scott Fetzer Co. on under FDA product code ECX (Cylinder, Compressed Gas, And Valve). FDA records list one 510(k) clearance for Western Enterprises, Inc. As of , FDA records show 5 recalls naming K142149.

Clearance record

Decision date
Received
(255 days to decision)
Product code
ECX Cylinder, Compressed Gas, And Valve
Regulation
21 CFR 868.2700
Device class
Class I
Review panel
Anesthesiology
Applicant
Western/Scott Fetzer Co. 875 Bassett Rd., Westlake OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ECX

Trailing 12 months

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

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