510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K024309Substantially Equivalent

The Vest Airway Clearance System, Model 104

Advanced Respiratory, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K024309 is the FDA 510(k) clearance record for THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104, a class II device, cleared for Advanced Respiratory on under FDA product code BYI (Percussor, Powered-Electric). FDA records list 2 510(k) clearances for Advanced Respiratory, from to . As of , FDA records show no recalls naming K024309.

Clearance record

Decision date
Received
(59 days to decision)
Product code
BYI Percussor, Powered-Electric
Regulation
21 CFR 868.5665
Device class
Class II
Review panel
Anesthesiology
Applicant
Advanced Respiratory 1020 W. County Rd. F, St. Paul MN
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