510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K040367Substantially Equivalent

Medpulse Respiratory Vest System, Model 2000Ez

Electromed, Inc., New Prague MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040367 is the FDA 510(k) clearance record for MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ, a class II device, cleared for Electromed, Inc. on under FDA product code BYI (Percussor, Powered-Electric). FDA records list 6 510(k) clearances for Electromed, Inc., from to . As of , FDA records show no recalls naming K040367.

Clearance record

Decision date
Received
(54 days to decision)
Product code
BYI Percussor, Powered-Electric
Regulation
21 CFR 868.5665
Device class
Class II
Review panel
Anesthesiology
Applicant
Electromed, Inc. 502 Sixth Ave. NW, New Prague MN
510(k) summary
Summary PDF
Third party review
No

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