510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963042Substantially Equivalent

Innosan Travelair S Portable Oxygen Concentrator, Code No. M407001853

Sim Italia S.r.l., Great Neck, NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963042 is the FDA 510(k) clearance record for INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853, a class II device, cleared for Sim Italia S.R.L. on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list 3 510(k) clearances for Sim Italia S.R.L., from to . As of , FDA records show no recalls naming K963042.

Clearance record

Decision date
Received
(88 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Sim Italia S.R.L. 55 Northern Blvd., Suite 410, Great Neck, NY
510(k) summary
Summary
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