Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kimberly-Clark Corporation — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
179 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231435 | KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Teste | Kimberly-Clark Corporation | 2023-08-28 | 103 | 0 |
| K231021 | KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for | Kimberly-Clark Corporation | 2023-07-21 | 102 | 0 |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2023-01-06 | 23 | 0 |
| K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with C | Kimberly Clark Corporation | 2020-11-30 | 98 | 0 |
| K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested | Kimberly-Clark Corporation | 2020-04-10 | 87 | 0 |
| K172118 | U by Kotex Click Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2017-10-11 | 90 | 0 |
| K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter S | Kimberly-Clark Corporation | 2014-12-02 | 29 | 0 |
| K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN | Kimberly-Clark Corporation | 2014-06-09 | 97 | 0 |
| K122653 | MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES | Kimberly-Clark Corporation | 2013-06-26 | 299 | 0 |
| K120650 | POISE PERSONAL LUBRICANT | Kimberly-Clark Corporation | 2012-07-11 | 131 | 0 |
| K113333 | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADUL | Kimberly-Clark Corporation | 2012-05-11 | 179 | 0 |
| K113036 | U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS | Kimberly-Clark Corporation | 2011-11-02 | 21 | 0 |
| K103311 | U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS | Kimberly Clark Corporation | 2010-12-10 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda