510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K834564Substantially Equivalent

Menstrual Pads

Probel-U.S., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834564 is the FDA 510(k) clearance record for MENSTRUAL PADS, a class II device, cleared for Probel-U.S., Inc. on under FDA product code HHL (Pad, Menstrual, Scented, Scented-Deodorized). FDA's definition for product code HHL reads: "Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for...". FDA records list one 510(k) clearance for Probel-U.S., Inc. As of , FDA records show no recalls naming K834564.

Clearance record

Decision date
Received
(93 days to decision)
Product code
HHL Pad, Menstrual, Scented, Scented-Deodorized
Regulation
21 CFR 884.5425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Probel-U.S., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HHL

Trailing 12 months

FDA records hold no clearances under product code HHL in the trailing twelve months.

FDA records show no clearances under product code HHL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260