510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902420Substantially Equivalent

Catheter, Nasal, Oxygen

Gainor Medical Europe, Ltd., Mcdonough GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902420 is the FDA 510(k) clearance record for CATHETER, NASAL, OXYGEN, a class I device, cleared for Gainor Medical Europe, Ltd. on under FDA product code CAT (Cannula, Nasal, Oxygen). FDA records list 13 510(k) clearances for Gainor Medical Europe, Ltd., from to . As of , FDA records show no recalls naming K902420.

Clearance record

Decision date
Received
(321 days to decision)
Product code
CAT Cannula, Nasal, Oxygen
Regulation
21 CFR 868.5340
Device class
Class I
Review panel
Anesthesiology
Applicant
Gainor Medical Europe, Ltd. P.O. Box 353, Mcdonough GA
Third party review
No

Clearances, product code CAT

Trailing 12 months

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

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