510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123400Substantially Equivalent

Aerobika Positive Expiratory Pressure Device

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

K123400 is the FDA 510(k) clearance record for AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE, a class II device, cleared for Trudell Medical Intl. on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list 15 510(k) clearances for Trudell Medical Intl., from to . As of , FDA records show no recalls naming K123400.

Clearance record

Decision date
Received
(192 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Trudell Medical Intl. 725 Third St., 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