510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K894384Substantially Equivalent

K.e.e. Oxygen Concentrator

Kee Medical Services, Inc., Mechanicsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894384 is the FDA 510(k) clearance record for K.E.E. OXYGEN CONCENTRATOR, a class II device, cleared for Kee Medical Services, Inc. on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list one 510(k) clearance for Kee Medical Services, Inc. As of , FDA records show no recalls naming K894384.

Clearance record

Decision date
Received
(102 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Kee Medical Services, Inc. 8 Belvedere Dr., Mechanicsburg PA
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