510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K113542Substantially Equivalent

Salter Labs Bubble Humidifier (High Flow)

Salter Labs, Arvin Facility, Arvin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113542 is the FDA 510(k) clearance record for SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW), a class II device, cleared for Salter Labs, Arvin Facility on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list one 510(k) clearance for Salter Labs, Arvin Facility. As of , FDA records show no recalls naming K113542.

Clearance record

Decision date
Received
(71 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
Salter Labs, Arvin Facility 100 Sycamore Rd., Arvin CA
510(k) summary
Summary PDF
Third party review
Yes

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