Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kendall — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
113 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT | Kendall | 2009-11-19 | 69 | 0 |
| K062671 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING A | Kendall | 2006-11-03 | 56 | 24 |
| K060972 | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREG | Kendall | 2006-08-04 | 119 | 38 |
| K053410 | GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR | Kendall | 2006-01-06 | 30 | 0 |
| K051584 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS | Kendall | 2005-10-06 | 113 | 4 |
| K043272 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTE | Kendall | 2004-12-22 | 26 | 0 |
| K042461 | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MO | Kendall | 2004-12-10 | 91 | 1 |
| K042572 | KENDALL CO2NFIRM NOW CO2 DETECTOR | Kendall | 2004-11-05 | 45 | 0 |
| K041914 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER | Kendall | 2004-09-27 | 73 | 0 |
| K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR | Kendall | 2004-05-19 | 30 | 0 |
| K040388 | NEXT GENERATION SALEM SUMP | Kendall | 2004-05-17 | 90 | 0 |
| K033676 | PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER | Kendall | 2004-02-20 | 88 | 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