Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kimberly-Clark — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
332 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113340 | KIMBERLY-CLARK CHILD'S FACEMASK | Kimberly-Clark | 2012-05-04 | 172 | 0 |
| K112562 | BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER | Kimberly-Clark | 2011-12-15 | 80 | 0 |
| K111402 | KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICAL | Kimberly-Clark | 2011-10-20 | 154 | 0 |
| K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | Kimberly-Clark | 2011-09-23 | 332 | 0 |
| K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOT | Kimberly-Clark | 2010-07-21 | 43 | 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