510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971545Substantially Equivalent

Protege Liquid Oxygen System

Healthdyne Technologies, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971545 is the FDA 510(k) clearance record for PROTEGE LIQUID OXYGEN SYSTEM, a class II device, cleared for Healthdyne Technologies, Inc. on under FDA product code BYJ (Unit, Liquid-Oxygen, Portable). FDA records list 9 510(k) clearances for Healthdyne Technologies, Inc., from to . As of , FDA records show no recalls naming K971545.

Clearance record

Decision date
Received
(88 days to decision)
Product code
BYJ Unit, Liquid-Oxygen, Portable
Regulation
21 CFR 868.5655
Device class
Class II
Review panel
Anesthesiology
Applicant
Healthdyne Technologies, Inc. 933 Western Dr., Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code BYJ

Trailing 12 months

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

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