510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854374Substantially Equivalent

Oxygen Concentrator, Model Bx-5000

Healthdyne, Inc., Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854374 is the FDA 510(k) clearance record for OXYGEN CONCENTRATOR, MODEL BX-5000, a class II device, cleared for Healthdyne, Inc. on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list 35 510(k) clearances for Healthdyne, Inc., from to . As of , FDA records show no recalls naming K854374.

Clearance record

Decision date
Received
(65 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Healthdyne, Inc. 1850 Pkwy. Pl., 12th Floor, Marietta GA
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