Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kimberly-Clark Health Care · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
606 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143053 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015-04-03 | 162 | 0 |
| K142782 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015-03-09 | 164 | 0 |
| K141612 | KIMGUARD ONE-STEP STERILIZATION WRAP | Kimberly-Clark Health Care | 2014-08-07 | 52 | 0 |
| K141071 | KIMGUARD ONE-STEP STERILIZATION WRAP | Kimberly-Clark Health Care | 2014-07-28 | 94 | 0 |
| K113806 | KIMGUARD ONE STEP STERILIZATION WRAP | Kimberly-Clark Health Care | 2013-08-20 | 606 | 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