510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K090915Substantially Equivalent

Sterile Water for Inhalation Flex Bag, Usp

Medtronic, Inc., Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090915 is the FDA 510(k) clearance record for STERILE WATER FOR INHALATION FLEX BAG, USP, a class II device, cleared for Cardinal Health, Inc. on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K090915.

Clearance record

Decision date
Received
(231 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
Cardinal Health, Inc. 1430 Waukegan Rd.- Mpkb-2b, Mcgaw Park IL
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 November 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BTT, trailing twelve months
MonthClearances
December 20251
January 20262
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260