510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K974849Substantially Equivalent

X-Air-Ciser

Hougen Mfg., Inc., Swartz Creek MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974849 is the FDA 510(k) clearance record for X-AIR-CISER, a class II device, cleared for Hougen Mfg., Inc. on under FDA product code BYI (Percussor, Powered-Electric). FDA records list 2 510(k) clearances for Hougen Mfg., Inc. As of , FDA records show no recalls naming K974849.

Clearance record

Decision date
Received
(220 days to decision)
Product code
BYI Percussor, Powered-Electric
Regulation
21 CFR 868.5665
Device class
Class II
Review panel
Anesthesiology
Applicant
Hougen Mfg., Inc. 3001 Hougen Dr., Swartz Creek MI
510(k) summary
Summary
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