510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052396Substantially Equivalent

Oxysure Portable Oxygen Generator, Model 615

Oxysure Systems, Inc., Frisco TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052396 is the FDA 510(k) clearance record for OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615, a class II device, cleared for Oxysure Systems, Inc. on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list one 510(k) clearance for Oxysure Systems, Inc. As of , FDA records show one recall naming K052396.

Clearance record

Decision date
Received
(100 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Oxysure Systems, Inc. 2611 Internet Blvd., Suite 109, Frisco TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAW

Trailing 12 months
12 clearances under product code CAW in the twelve months to October 2026, December 2025 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code CAW, trailing twelve months
MonthClearances
November 20251
December 20255
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260