510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833351Substantially Equivalent

Demand Oxygen Controller

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

K833351 is the FDA 510(k) clearance record for DEMAND OXYGEN CONTROLLER, a class I device, cleared for Healthdyne, Inc. on under FDA product code BZB (Catheter, Nasal, Oxygen). FDA records list 35 510(k) clearances for Healthdyne, Inc., from to . As of , FDA records show no recalls naming K833351.

Clearance record

Decision date
Received
(173 days to decision)
Product code
BZB Catheter, Nasal, Oxygen
Regulation
21 CFR 868.5350
Device class
Class I
Review panel
Anesthesiology
Applicant
Healthdyne, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BZB

Trailing 12 months

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

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