Kimberly-Clark Corp.: FDA filings under this applicant name
FDA lists 120 510(k) clearances under the applicant name “Kimberly-Clark Corp.” (first 1978, latest 2023), across 36 product codes in 6 review panels. Median 510(k) review time under this name: 68 days. Since 2017 the median was 90 days, against 131 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 172 |
| 2013 | 4 | 159 |
| 2014 | 4 | 98 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 90 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 87 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 3 | 102 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kimberly-Clark Corp. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 15 | 15 |
| HHD | Pad, Menstrual, Unscented | 13 | 13 |
| FYA | Gown, Surgical | 12 | 12 |
| FRG | Wrap, Sterilization | 11 | 11 |
| LZA | Polymer Patient Examination Glove | 10 | 10 |
| KKX | Drape, Surgical, Antimicrobial | 8 | 8 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 7 | 7 |
| BTR | Tube, Tracheal (W/Wo Connector) | 4 | 4 |
| FXX | Mask, Surgical | 4 | 4 |
| KME | Bedding, Disposable, Medical | 3 | 3 |
Plus 26 more product codes.
Review panels
- General Hospital (62)
- Obstetrics and Gynecology (38)
- Anesthesiology (6)
- Gastroenterology and Urology (6)
- General and Plastic Surgery (5)
- Cardiovascular (1)
Most recent Kimberly-Clark Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231435 | KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | 2023-08-28 | 103 |
| K231021 | KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | 2023-07-21 | 102 |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | HEB | 2023-01-06 | 23 |
| K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid | LZA | 2020-04-10 | 87 |
| K172118 | U by Kotex Click Unscented Menstrual Tampons | HEB | 2017-10-11 | 90 |
| K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | BSO | 2014-12-02 | 29 |
| K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP | FRG | 2014-11-10 | 209 |
| K141294 | U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS | HEB | 2014-08-25 | 98 |
| K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN | FYA | 2014-06-09 | 97 |
| K131879 | KC 300 SURGICAL MASK | FXX | 2013-12-20 | 179 |
110 earlier clearances. See the full list in Caduvo.
Recalls
35 product recalls in 19 recall events; 0 initiated in the last five years. Most recent: 2018-12-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Kimberly-Clark Corp. is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07561905: Tampon Safety-in-Use Study (Recruiting, started 2026-04-27)
- NCT05553600: Tampon Design Validation Study (Completed, started 2022-10-21)
- NCT04620356: Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE) (Completed, started 2020-02-21)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kimberly-Clark Health Care (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kimberly-Clark Corp.?
FDA lists 120 510(k) clearances under the applicant name “Kimberly-Clark Corp.” (first 1978, latest 2023), across 36 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kimberly-Clark Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kimberly-Clark Corp. is 68 days. Since 2017: 90 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kimberly-Clark Corp.?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 15); HHD (Pad, Menstrual, Unscented, 13); FYA (Gown, Surgical, 12).
Next steps
- See all 120 Kimberly-Clark Corp. clearances with predicates and recalls
- Run predicate analysis for product code HEB, Kimberly-Clark Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.