510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091557Substantially Equivalent

Lung Flute Therapeutic

Medical Acoustics, Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091557 is the FDA 510(k) clearance record for LUNG FLUTE THERAPEUTIC, a class II device, cleared for Medical Acoustics on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list 2 510(k) clearances for Medical Acoustics, from to . As of , FDA records show no recalls naming K091557.

Clearance record

Decision date
Received
(222 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Medical Acoustics 255 Great Arrow Ave. Suite 23, Buffalo NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BWF

Trailing 12 months

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

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