510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K984295Substantially Equivalent

Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)

Invacare GmbH, Elyria OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984295 is the FDA 510(k) clearance record for INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS), a class II device, cleared for Invacare Corp. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 131 510(k) clearances for Invacare Corp., from to . As of , FDA records show no recalls naming K984295.

Clearance record

Decision date
Received
(220 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Invacare Corp. One Invacare Way, Elyria OH
510(k) summary
Summary
Third party review
No

Clearances, product code CCL

Trailing 12 months
1 clearance under product code CCL in the twelve months to November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260