510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131386Substantially Equivalent

Ez-Ox Plus Generation II

Air Liquide Healthcare America, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131386 is the FDA 510(k) clearance record for EZ-OX PLUS GENERATION II, a class I device, cleared for Air Liquide Healthcare America on under FDA product code ECX (Cylinder, Compressed Gas, And Valve). FDA records list 4 510(k) clearances for Air Liquide Healthcare America, from to . As of , FDA records show no recalls naming K131386.

Clearance record

Decision date
Received
(304 days to decision)
Product code
ECX Cylinder, Compressed Gas, And Valve
Regulation
21 CFR 868.2700
Device class
Class I
Review panel
Anesthesiology
Applicant
Air Liquide Healthcare America 2700 Post Oak Blvd. Suite 1800, Houston TX
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