Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Kendall Company · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
203 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061936 | KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 | The Kendall Company | 2006-08-09 | 30 | 0 |
| K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR | The Kendall Company | 2003-05-13 | 112 | 3 |
| K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | The Kendall Company | 2002-04-10 | 90 | 25 |
| K011283 | MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE | The Kendall Company | 2001-10-15 | 171 | 0 |
| K011941 | EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 | The Kendall Company | 2001-08-22 | 62 | 0 |
| K002902 | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMB | The Kendall Company | 2001-04-09 | 203 | 5 |
| K002901 | KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER | The Kendall Company | 2001-03-28 | 191 | 0 |
| K003313 | FILAC FAS TEMP ELECTRONIC THERMOMETER | The Kendall Company | 2001-01-11 | 80 | 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