510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183108Substantially Equivalent

Combined Aerobika OPEP and VersaPAP device

Trudell Medical International, London, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183108 is the FDA 510(k) clearance record for Combined Aerobika OPEP and VersaPAP device, a class II device, cleared for Trudell Medical International on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list 9 510(k) clearances for Trudell Medical International, from to . As of , FDA records show no recalls naming K183108.

Clearance record

Decision date
Received
(281 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Trudell Medical International 725 Baransway Dr., London, CA
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