510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K841295Substantially Equivalent

Hypothermia Oxygen Warmer-Treatment Sys

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

K841295 is the FDA 510(k) clearance record for HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS, a class II device, cleared for Bow/Parm on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list one 510(k) clearance for Bow/Parm. As of , FDA records show no recalls naming K841295.

Clearance record

Decision date
Received
(132 days to decision)
Product code
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation
21 CFR 868.5450
Device class
Class II
Review panel
Anesthesiology
Applicant
Bow/Parm 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BTT

Trailing 12 months
5 clearances under product code BTT in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BTT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260