510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760584Substantially Equivalent

U-Mid Prefilled Humidifier (500Cc)

BD Becton Dickinson Vacutainer Systems Preanalytic, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760584 is the FDA 510(k) clearance record for U-MID PREFILLED HUMIDIFIER (500CC), a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K760584.

Clearance record

Decision date
Received
(42 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
Bd Becton Dickinson Vacutainer Systems Preanalytic 1875 Eye St. NW Suite 625, Washington DC
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