Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LFJ · Predicate Candidate Screening
65 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
428 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920780 | MEDSURG INSERTION TRAY | Medsurg Industries, Inc. | 1994-08-19 | 911 | 0 |
| K925819 | AKCESS0CATH KIT | Akcess Medical Products, Inc. | 1994-08-02 | 623 | 0 |
| K925818 | AKCESS-CATH | Akcess Medical Products, Inc. | 1994-04-05 | 504 | 0 |
| K913468 | ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY | Cook, Inc. | 1994-03-24 | 962 | 0 |
| K931120 | COAXIAL ACUTE CATHETER | Akcess Medical Products, Inc. | 1994-01-14 | 316 | 0 |
| K920634 | SPLITTABLE SHEATH INTRODUCER SET | Akcess Medical Products, Inc. | 1994-01-14 | 702 | 0 |
| K914162 | VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS | Vas-Cath, Inc. | 1993-07-01 | 653 | 0 |
| K915423 | HEMO-CATH SILICONE ACCESS CATHETER | Medical Components, Inc. | 1993-02-02 | 428 | 0 |
| K914826 | AKCESS-CATH KIT | Akcess Medical Products, Inc. | 1992-04-10 | 168 | 0 |
| K910501 | PERMANENT SILICONE CATHETERS | Akcess Medical Products, Inc. | 1991-04-29 | 83 | 0 |
| K905080 | MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1991-01-31 | 79 | 0 |
| K904139 | SINGLE LUMEN CATHETER KITS | Akcess Medical Products, Inc. | 1990-12-04 | 89 | 0 |
| K904140 | SINGLE LUMEN CATHETERS, MODIFICATION | Akcess Medical Products, Inc. | 1990-11-27 | 82 | 0 |
| K901133 | DURACATH | Impra, Inc. | 1990-06-08 | 88 | 0 |
| K901061 | SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000 | Akcess Medical Products, Inc. | 1990-05-22 | 78 | 0 |
| K900835 | MODIFIED PERM-CATH | Quinton, Inc. | 1990-05-09 | 76 | 0 |
| K896568 | DUALYSE-CATH - CODES #1132.212, 1132.112 | Vygon Corp. | 1990-05-09 | 170 | 0 |
| K900803 | DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S | Akcess Medical Products, Inc. | 1990-04-25 | 64 | 0 |
| K895506 | FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER | Vas-Cath, Inc. | 1990-02-09 | 150 | 0 |
| K895417 | ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT | Arrow Intl., Inc. | 1990-01-03 | 124 | 1 |
| K893439 | HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C | Medical Components, Inc. | 1989-06-13 | 41 | 1 |
| K891753 | DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800 | Akcess Medical Products, Inc. | 1989-06-08 | 77 | 0 |
| K891755 | DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K | Akcess Medical Products, Inc. | 1989-06-08 | 77 | 0 |
| K884322 | SUBCLAVIAN HEMODIALYSIS CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-04-25 | 193 | 0 |
| K890029 | HEMO-CATH SILICONE DOUBLE LUMEN CATHETER | Medical Components, Inc. | 1989-04-17 | 103 | 1 |
| K890099 | MODIFIED VAS-CATH CATHETER REPAIR KIT | Vas-Cath, Inc. | 1989-04-11 | 91 | 0 |
| K883592 | IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER | Impra, Inc. | 1988-12-08 | 107 | 0 |
| K883768 | VAS-CATH CATHETER REPAIR KIT | Vas-Cath, Inc. | 1988-11-14 | 69 | 0 |
| K880778 | MEDSURG ACUTE DIALYSIS TRAY | Medsurg Industries, Inc. | 1988-07-15 | 140 | 0 |
| K881695 | DESERET SUBCLAVIAN HEMODIALYSIS CATHETER | Deseret Medical, Inc. | 1988-06-23 | 65 | 0 |
| K881743 | VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER | Vas-Cath, Inc. | 1988-06-23 | 62 | 0 |
| K881290 | MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1988-04-27 | 30 | 0 |
| K875188 | LUER LOCK CONNECTORS / RIDIG P.V.C. | Vas-Cath of Canada , Ltd. | 1988-03-02 | 76 | 0 |
| K874633 | PERMCATH INSERTION TRAY | Quinton, Inc. | 1988-02-17 | 100 | 0 |
| K871749 | ADULT PERM-CATH 40CM. | Quinton, Inc. | 1987-06-17 | 43 | 0 |
| K871942 | PERM-CATH CATHETER KIT | Quinton, Inc. | 1987-06-17 | 29 | 0 |
| K871488 | VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH | Vas-Cath of Canada , Ltd. | 1987-06-12 | 58 | 0 |
| K871487 | VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH | Vas-Cath of Canada , Ltd. | 1987-06-12 | 58 | 0 |
| K870328 | SINGLE LUMEN ACUTE CATHETER | Quinton, Inc. | 1987-05-11 | 103 | 0 |
| K863697 | MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1986-10-02 | 10 | 0 |
| K861174 | SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1986-04-23 | 29 | 0 |
| K860094 | HURWITZ DIALYSIS CATHETER | Gish Biomedical, Inc. | 1986-04-07 | 87 | 0 |
| K853283 | VACCESS TM 4006 | Vas-Cath of Canada , Ltd. | 1985-08-22 | 17 | 0 |
| K852070 | SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL | Shiley, Inc. | 1985-06-13 | 34 | 0 |
| K852162 | MNI 400 INJECTION CAPS | Med-West, Inc. | 1985-06-12 | 23 | 0 |
| K844336 | VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH | Vas-Cath of Canada , Ltd. | 1985-03-13 | 125 | 0 |
| K844434 | VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH | Vas-Cath of Canada , Ltd. | 1985-03-13 | 117 | 0 |
| K844433 | VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA | Vas-Cath of Canada , Ltd. | 1985-03-13 | 117 | 1 |
| K840197 | SINGLE LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1984-04-25 | 98 | 0 |
| K833848 | DUAL LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1983-12-08 | 34 | 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