510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203209Substantially Equivalent

AirPhysio Positive Expiratory Pressure (PEP) Device

Airphysio Pty, Ltd., Tweed Heads South, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203209 is the FDA 510(k) clearance record for AirPhysio Positive Expiratory Pressure (PEP) Device, a class II device, cleared for Airphysio Pty, Ltd. on under FDA product code BYI (Percussor, Powered-Electric). FDA records list one 510(k) clearance for Airphysio Pty, Ltd. As of , FDA records show no recalls naming K203209.

Clearance record

Decision date
Received
(77 days to decision)
Product code
BYI Percussor, Powered-Electric
Regulation
21 CFR 868.5665
Device class
Class II
Review panel
Anesthesiology
Applicant
Airphysio Pty, Ltd. Unit 1, 43 Greenway Dr., Tweed Heads South, AU
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code BYI

Trailing 12 months
1 clearance under product code BYI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BYI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260