Data / Medical devices / United States / Kimberly-Clark Corporation
Kimberly-Clark Corporation: FDA-registered device maker in Neenah, WI, United States, 4 510(k) clearances
Kimberly-Clark Corporation is registered with the FDA (registration 3003701733) in Neenah, WI, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 13, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003701733
- Address
- 2100 Winchester RD., Neenah, WI, United States, 54956
- Owner or operator
- KIMBERLY-CLARK CORPORATION (9001775)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- April 5, 2001
- Registered through
- 2026
- Brand names listed
- Depend, Kotex, Poise, Speax, Thinx, Thinx Teen, U by Kotex, goodnites
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Reusable | NUQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 13, 2025 | K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | HEB | Substantially Equivalent | Unibeauty (Hubei) Technology Co., Ltd. | accessdata.fda.gov |
| January 6, 2023 | K223749 | U by Kotex® Click® Unscented Menstrual Tampons | HEB | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| October 11, 2017 | K172118 | U by Kotex Click Unscented Menstrual Tampons | HEB | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| August 27, 2013 | K131198 | TIPI OTC | HHW | Substantially Equivalent | Contipi , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 11, 2018 | 81759 | Class II | Terminated | U by Kotex Sleek, Regular Tampons, 18 Count | Potential for tampon to come apart upon removal. | accessdata.fda.gov |
Compare with other makers
- All makers of Pessary, Vaginal
- All makers of Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile
- All makers of Tampon, Menstrual, Unscented
- All makers of Pad, Menstrual, Reusable
- All makers of Garment, Protective, For Incontinence
- All makers of Pad, Menstrual, Unscented
Updated August 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.