Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NIE — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
206 daysmedian FDA review time
316 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | 2023-11-16 | 57 | 0 |
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Health Line International Corporation | 2023-01-13 | 176 | 0 |
| K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019-06-14 | 206 | 0 |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2018-07-05 | 64 | 0 |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infu | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015-07-24 | 268 | 1 |
| K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | C.R. Bard, Inc. | 2015-06-01 | 357 | 1 |
| K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER | C.R. Bard, Inc. | 2014-09-24 | 316 | 1 |
| K123292 | T3 | Medcomp | 2013-06-11 | 232 | 0 |
| K102605 | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-12-22 | 103 | 25 |
| K083675 | POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER | C.R. Bard, Inc. | 2009-03-19 | 98 | 0 |
| K033570 | MEDCOMP T-3 | Medcomp | 2004-09-16 | 309 | 0 |
| K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | The Kendall Company | 2002-04-10 | 90 | 25 |
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