Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Components, Inc. — Predicate Candidate Screening
63 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
354 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | Medical Components, Inc. | 2025-08-12 | 145 | 0 |
| K141633 | PRO-PICC WITH VALVE TECHNOLOGY | Medical Components, Inc. | 2014-09-29 | 103 | 0 |
| K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE | Medical Components, Inc. | 2014-01-08 | 117 | 0 |
| K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET | Medical Components, Inc. | 2013-08-16 | 67 | 0 |
| K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER | Medical Components, Inc. | 2013-08-15 | 155 | 1 |
| K130923 | 5F DIGNITY CT TITANIUM PORT | Medical Components, Inc. | 2013-07-31 | 119 | 0 |
| K124046 | VALVED TEARAWAY INTRODUCER GENERATION II | Medical Components, Inc. | 2013-06-03 | 154 | 0 |
| K123617 | 3F PRO-PICC | Medical Components, Inc. | 2013-05-15 | 173 | 0 |
| K122423 | VASU-PICC | Medical Components, Inc. | 2012-12-12 | 125 | 0 |
| K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM | Medical Components, Inc. | 2012-09-21 | 88 | 1 |
| K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT | Medical Components, Inc. | 2012-09-17 | 230 | 0 |
| K121383 | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CA | Medical Components, Inc. | 2012-09-05 | 120 | 0 |
| K121094 | MEDCOMP VASCU-PICC & MIDLINE CATHETERS | Medical Components, Inc. | 2012-06-06 | 57 | 0 |
| K120981 | 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC | Medical Components, Inc. | 2012-05-02 | 30 | 0 |
| K120980 | 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC | Medical Components, Inc. | 2012-05-02 | 30 | 0 |
| K113487 | HEMO-CATH 10F, HEMO-CATH 12.5F | Medical Components, Inc. | 2012-03-09 | 107 | 0 |
| K111651 | SPLIT CATH III | Medical Components, Inc. | 2011-12-08 | 178 | 1 |
| K012562 | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER | Medical Components, Inc. | 2002-02-08 | 184 | 0 |
| K994105 | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS- | Medical Components, Inc. | 2001-10-03 | 667 | 1 |
| K011576 | MEDCOMP ASH SPLIT | Medical Components, Inc. | 2001-06-21 | 30 | 0 |
| K003207 | MEDCOMP ULTRA-FLOW CATHETER | Medical Components, Inc. | 2001-06-12 | 242 | 0 |
| K010021 | MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S | Medical Components, Inc. | 2001-02-23 | 51 | 0 |
| K003682 | MEDCOMP Z-CATH | Medical Components, Inc. | 2001-01-26 | 57 | 2 |
| K991320 | MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN | Medical Components, Inc. | 1999-11-10 | 205 | 0 |
| K980438 | 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20 | Medical Components, Inc. | 1999-06-10 | 491 | 0 |
| K983511 | SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE | Medical Components, Inc. | 1999-06-08 | 244 | 0 |
| K974236 | MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF14 | Medical Components, Inc. | 1999-04-15 | 519 | 0 |
| K981125 | MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 | Medical Components, Inc. | 1999-02-26 | 336 | 0 |
| K983412 | MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, | Medical Components, Inc. | 1998-12-10 | 73 | 0 |
| K973561 | MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM | Medical Components, Inc. | 1998-05-11 | 234 | 0 |
| K971925 | MEDCOMP BIO-FLEX CS CATHETER (CS100) | Medical Components, Inc. | 1998-02-23 | 276 | 1 |
| K960426 | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER | Medical Components, Inc. | 1996-03-21 | 52 | 0 |
| K923691 | TWIN SILICONE CATHETER | Medical Components, Inc. | 1995-09-25 | 1159 | 0 |
| K915490 | MEDCOMP PERITONEAL DIALYSIS CATHETERS | Medical Components, Inc. | 1994-02-02 | 789 | 0 |
| K930539 | MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY | Medical Components, Inc. | 1993-08-27 | 206 | 0 |
| K915423 | HEMO-CATH SILICONE ACCESS CATHETER | Medical Components, Inc. | 1993-02-02 | 428 | 0 |
| K905021 | ACETATE CONCENTRATES FOR HEMODIALYSIS | Medical Components, Inc. | 1991-03-15 | 128 | 0 |
| K893439 | HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C | Medical Components, Inc. | 1989-06-13 | 41 | 1 |
| K890029 | HEMO-CATH SILICONE DOUBLE LUMEN CATHETER | Medical Components, Inc. | 1989-04-17 | 103 | 1 |
| K883899 | MANUAL PERCUSSOR CUPS | Medical Components, Inc. | 1988-12-13 | 89 | 0 |
| K873344 | ESOPHAGEAL STETHOSCOPE W/THERMISTOR | Medical Components, Inc. | 1987-10-20 | 62 | 0 |
| K863661 | MEDCOMP DISPOSABLE MANIFOLD SYSTEM | Medical Components, Inc. | 1986-09-29 | 11 | 0 |
| K862771 | MEDCOMP C.A.V.H. CATHETER | Medical Components, Inc. | 1986-08-06 | 15 | 0 |
| K860867 | DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS | Medical Components, Inc. | 1986-07-02 | 117 | 0 |
| K860810 | MEDCOMP'S FEMORAL VEIN CATHETERS | Medical Components, Inc. | 1986-04-08 | 35 | 0 |
| K854984 | CUP MONITORING KIT CVPK-14 | Medical Components, Inc. | 1986-03-31 | 109 | 0 |
| K850861 | ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE | Medical Components, Inc. | 1986-02-18 | 354 | 0 |
| K860155 | PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 | Medical Components, Inc. | 1986-02-14 | 29 | 0 |
| K842416 | DUO FLOW CATHETER-MC 54 | Medical Components, Inc. | 1984-07-26 | 36 | 0 |
| K841530 | DOUBLE LUMEN SUBLCAVIAN-FEMORAL | Medical Components, Inc. | 1984-06-25 | 83 | 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