FDA applicant
Kimberly-Clark Corp.
FDA records 122 decisions for Kimberly-Clark Corp. (Roswell, GA) from 1978 to 2023: 122 510(k) clearances. Most are in product codes HEB (Tampon, Menstrual, Unscented) and HHD (Pad, Menstrual, Unscented). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 69 predicates, 41 of them its own earlier devices. 25 recalls are linked to its devices, 5 Class I.
FDA’s records also spell it “Kimberly-Clark Corporation”, “Kimberly-Clark”, “Kimberly Clark Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Kimberly-Clark Corp.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Kimberly-Clark Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Kimberly-Clark”
FDA records each applicant name separately; these may or may not be the same firm.