510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904026Substantially Equivalent

Inflat-O-Ball

Milex Products, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904026 is the FDA 510(k) clearance record for INFLAT-O-BALL, a class II device, cleared for Milex Products, Inc. on under FDA product code HHW (Pessary, Vaginal). FDA records list 8 510(k) clearances for Milex Products, Inc., from to . As of , FDA records show 13 recalls naming K904026.

Clearance record

Decision date
Received
(41 days to decision)
Product code
HHW Pessary, Vaginal
Regulation
21 CFR 884.3575
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Milex Products, Inc. 5915 Northwest Hwy., Chicago IL
Third party review
No

Clearances, product code HHW

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