510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843212Substantially Equivalent

Low Pressure Alarm for Oxygen Cylinder

Hospitak, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843212 is the FDA 510(k) clearance record for LOW PRESSURE ALARM FOR OXYGEN CYLINDER, a class I device, cleared for Hospitak, Inc. on under FDA product code BXH (Gauge, Gas Pressure, Cylinder/Pipeline). FDA records list 27 510(k) clearances for Hospitak, Inc., from to . As of , FDA records show no recalls naming K843212.

Clearance record

Decision date
Received
(35 days to decision)
Product code
BXH Gauge, Gas Pressure, Cylinder/Pipeline
Regulation
21 CFR 868.2610
Device class
Class I
Review panel
Anesthesiology
Applicant
Hospitak, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BXH

Trailing 12 months

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

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