510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903489Substantially Equivalent

Thera-Mist Tm Volumina Incent Spirometer, P40000

Pegasus Research Corp., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903489 is the FDA 510(k) clearance record for THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000, a class II device, cleared for Pegasus Research Corp. on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list 12 510(k) clearances for Pegasus Research Corp., from to . As of , FDA records show no recalls naming K903489.

Clearance record

Decision date
Received
(130 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Pegasus Research Corp. 3001 Redhill Ave., Suite 4-, Costa Mesa CA
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