Medical Components, Inc.
Harleysville, PA, US
MEDICAL COMPONENTS INC appears in FDA device records in Harleysville, PA. FDA records list 72 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 46 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Medical Components, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medical Components, Inc. (dba MedComp)510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 72FDA records hold 72 510(k) clearances for Medical Components, Inc. between 1980 and 2025. The busiest year on record is 1980, with 9. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 9 |
| 1982 | 2 |
| 1984 | 4 |
| 1986 | 7 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 2 |
| 1991 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 3 |
| 1999 | 5 |
| 2001 | 5 |
| 2002 | 1 |
| 2011 | 1 |
| 2012 | 8 |
| 2013 | 5 |
| 2014 | 2 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 2 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | MPB | Substantially Equivalent | |
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | NIE | Unknown | |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes | MSD | Substantially Equivalent | |
| K192807 | Duo-Flow Side x Side Double Lumen Catheter | MPB | Substantially Equivalent | |
| K183219 | Trio-CT Triple Lumen Catheter | NIE | Unknown | |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | NIE | Unknown | |
| K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes | MSD | Unknown | |
| K180567 | C3 Wave System | LJS | Substantially Equivalent | |
| K170934 | C3 Wave System | LJS | Substantially Equivalent | |
| K170770 | CT Midline | PND | Substantially Equivalent | |
| K141633 | PRO-PICC WITH VALVE TECHNOLOGY | LJS | Substantially Equivalent | |
| K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE | FPA | Substantially Equivalent | |
| K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET | LJS | Substantially Equivalent | |
| K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER | DYB | Substantially Equivalent | |
| K130923 | 5F DIGNITY CT TITANIUM PORT | LJT | Substantially Equivalent | |
| K124046 | VALVED TEARAWAY INTRODUCER GENERATION II | DYB | Substantially Equivalent | |
| K123617 | 3F PRO-PICC | LJS | Substantially Equivalent | |
| K122423 | VASU-PICC | LJS | Substantially Equivalent | |
| K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | MSD | Unknown | |
| K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT | LJT | Substantially Equivalent | |
| K121383 | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) | FJS | Unknown | |
| K121094 | MEDCOMP VASCU-PICC & MIDLINE CATHETERS | LJS | Substantially Equivalent | |
| K120981 | 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC | LJS | Substantially Equivalent | |
| K120980 | 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC | LJS | Substantially Equivalent | |
| K113487 | HEMO-CATH 10F, HEMO-CATH 12.5F | MSD | Unknown | |
| K111651 | SPLIT CATH III | MSD | Unknown | |
| K012562 | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | |
| K994105 | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | MSD | Substantially Equivalent | |
| K011576 | MEDCOMP ASH SPLIT | NFK | Substantially Equivalent | |
| K003207 | MEDCOMP ULTRA-FLOW CATHETER | MSD | Substantially Equivalent | |
| K010021 | MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S | FOZ | Substantially Equivalent | |
| K003682 | MEDCOMP Z-CATH | LJS | Substantially Equivalent | |
| K991320 | MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN | MPB | Substantially Equivalent | |
| K980438 | 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT | MPB | Substantially Equivalent | |
| K983511 | SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH | MPB | Substantially Equivalent | |
| K974236 | MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB | MPB | Substantially Equivalent | |
| K981125 | MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 | MSD | Substantially Equivalent | |
| K983412 | MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T | LJS | Substantially Equivalent | |
| K973561 | MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M | FOZ | Substantially Equivalent | |
| K971925 | MEDCOMP BIO-FLEX CS CATHETER (CS100) | MSD | Substantially Equivalent | |
| K960426 | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER | GBW | Substantially Equivalent | |
| K923691 | TWIN SILICONE CATHETER | MPB | Unknown | |
| K915490 | MEDCOMP PERITONEAL DIALYSIS CATHETERS | FJS | Unknown | |
| K930539 | MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY | BSO | Substantially Equivalent | |
| K915423 | HEMO-CATH SILICONE ACCESS CATHETER | LFJ | Unknown | |
| K905021 | ACETATE CONCENTRATES FOR HEMODIALYSIS | KPO | Substantially Equivalent | |
| K893439 | HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C | LFJ | Substantially Equivalent | |
| K890029 | HEMO-CATH SILICONE DOUBLE LUMEN CATHETER | LFJ | Substantially Equivalent | |
| K883899 | MANUAL PERCUSSOR CUPS | BYI | Substantially Equivalent | |
| K873344 | ESOPHAGEAL STETHOSCOPE W/THERMISTOR | BZT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2518902 | 2518902 | MEDICAL COMPONENTS INC | 1499 DELP DRIVE, HARLEYSVILLE, PA 19438 US | 2026 | and 24 more, listed in full below |
| 3013750125 | 3013750125 | Medical Components, Inc. | 3088 East 33rd Place, Yuma, AZ 85365 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNZAccessories, A-V Shunt
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- BSOCatheter, Conduction, Anesthetic
- LFKCatheter, Femoral
- MSDCatheter, Hemodialysis, Implanted
- MPBCatheter, Hemodialysis, Non-Implanted
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted
- JCYCatheter, Infusion
- DQOCatheter, Intravascular, Diagnostic
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GBXCatheter, Irrigation
- DQYCatheter, Percutaneous
- GBWCatheter, Peritoneal
- FKOCatheter, Peritoneal Dialysis, Single Use
- FJSCatheter, Peritoneal, Long-Term Indwelling
- LFJCatheter, Subclavian
- GBSCatheter, Ventricular, General & Plastic Surgery
- HXDClamp
- DXCClamp, Vascular
- KMKDevice, Intravascular Catheter Securement
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- DREDilator, Vessel, For Percutaneous Catheterization
- MZYGraft, Vascular, Stainless Steel Tunneler
- GDFGuide, Needle, Surgical
- DXTInjector And Syringe, Angiographic
- LFLInstrument, Ultrasonic Surgical
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- NFKKit, Repair, Catheter, Hemodialysis
- PNDMidline Catheter
- GCBNeedle, Catheter
- FIENeedle, Fistula
- PTINon-Coring (Huber) Needle
- BYIPercussor, Powered-Electric
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- NGTSaline, Vascular Access Flush
- FPASet, Administration, Intravascular
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)
- FIFSet, Dialysis, Single Needle With Uni-Directional Pump
- BZWStethoscope, Esophageal
- BZTStethoscope, Esophageal, With Electrical Conductors
- GAHStylet, Surgical, General & Plastic Surgery
- FMFSyringe, Piston
- DRCTrocar
- KNTTubes, Gastrointestinal (And Accessories)
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 46| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1184-2021 | Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system. | The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure. | Class II | Open, Classified | |
| Z-2940-2020 | Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024 | Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer | Class II | Terminated | |
| Z-2217-2019 | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. | Class II | Terminated | |
| Z-2216-2019 | 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. | Class II | Terminated | |
| Z-2215-2019 | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. | Class II | Terminated | |
| Z-1149-2019 | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422 | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. | Class II | Terminated | |
| Z-0222-2020 | C3 Wave App, v. 2.0.5 | When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement. | Class II | Terminated | |
| Z-2942-2018 | DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL, SYRINGE, AND NEEDLE, XTP118IJS-ID; DOUBLE LUMEN CATHETER WITH CURVED EXTENSIONS (CATHETER ONLY), XTP114IJC=, XTP116IJC=, DOUBLE LUMEN IJ CATHETER SET, XTP114IJS=, XTP115IJS=, XTP116IJS=, XTP116IJS=JO, DOUBLE LUMEN CATHETER SET, XTP114MT= DUO-FLOW DOUBLE LUMEN CATHETER, XTP116CT, INTERNAL JUGULAR CATHETER SET, XTP96IJS= (additional product codes/catalog numbers in attached spreadsheet) | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2941-2018 | DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67 | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2940-2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2939-2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424 | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2938-2018 | Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2937-2018 | Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2936-2018 | Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2935-2018 | Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2934-2018 | Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2933-2018 | Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15 | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-2932-2018 | Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108 | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | Class II | Terminated | |
| Z-1127-2018 | REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. | Class II | Terminated | |
| Z-1126-2018 | CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. | Class II | Terminated | |
| Z-1125-2018 | TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. | Class II | Terminated | |
| Z-1124-2018 | 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. | Class II | Terminated | |
| Z-1123-2018 | 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. | Class II | Terminated | |
| Z-1122-2018 | 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. | Class II | Terminated | |
| Z-1121-2018 | 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain