510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843243Substantially Equivalent

Companion 492 Oxygen Concentrator

Medtronic, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843243 is the FDA 510(k) clearance record for COMPANION 492 OXYGEN CONCENTRATOR, a class II device, cleared for Puritan Bennett Corp. on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K843243.

Clearance record

Decision date
Received
(368 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Puritan Bennett Corp. 4221 Richmond Rd., NW, Walker MI
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