510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K930149Substantially Equivalent

Kotex Discrete Digital Tampons, Reg.,super,super+

Kimberly-Clark Corporation, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930149 is the FDA 510(k) clearance record for KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+, a class II device, cleared for Kimberly-Clark Corp. on under FDA product code HEB (Tampon, Menstrual, Unscented). FDA's definition for product code HEB reads: "An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge". FDA records list 122 510(k) clearances for Kimberly-Clark Corp., from to . As of , FDA records show no recalls naming K930149.

Clearance record

Decision date
Received
(414 days to decision)
Product code
HEB Tampon, Menstrual, Unscented
Regulation
21 CFR 884.5470
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Kimberly-Clark Corp. 700 11th St., NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code HEB

Trailing 12 months
2 clearances under product code HEB in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HEB, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260