510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K843015Substantially Equivalent

Sanitary Panty W/pads & Designed

Hygienics Industries, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843015 is the FDA 510(k) clearance record for SANITARY PANTY W/PADS & DESIGNED, a class I device, cleared for Hygienics Industries, Inc. on under FDA product code HHD (Pad, Menstrual, Unscented). FDA's definition for product code HHD reads: "An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile". FDA records list one 510(k) clearance for Hygienics Industries, Inc. As of , FDA records show no recalls naming K843015.

Clearance record

Decision date
Received
(66 days to decision)
Product code
HHD Pad, Menstrual, Unscented
Regulation
21 CFR 884.5435
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Hygienics Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HHD

Trailing 12 months

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

FDA records show no clearances under product code HHD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHD, 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