# Medical Components, Inc.

- Location (FDA's records): Harleysville, PA
- FDA decisions: 64 (1980–2026): 64 510(k) clearances
- Product codes: LJS (10), MSD (8), MPB (6), LFJ (5), FOZ (3), DQO (3), LJT (2), DYB (2), DQY (2), FJS (2), KNZ (2), LFK (2)
- Predicates its devices cite: 39 (10 its own); citations of its devices by later devices: 46 (10 its own)
- Recalls linked to its devices: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medcomp: 19 (https://510kreport.com/company/medcomp)
- C.R. Bard, Inc.: 3 (https://510kreport.com/company/cr-bard)
- Medcomp ( Medical Components): 2 (https://510kreport.com/company/medcomp-medical-components)
- Medical Components, Inc. (dba MedComp): 1 (https://510kreport.com/company/medical-components-dba-medcomp)
- Medigroup: 1 (https://510kreport.com/company/medigroup)
- Accurate Surgical Instruments Co.: 1 (https://510kreport.com/company/accurate-surgical-instruments)
- Medpro Safety Products, Inc.: 1 (https://510kreport.com/company/medpro-safety-products)
- Phs Medical GmbH: 1 (https://510kreport.com/company/phs-medical)

## Firms that cite its devices most
- Medcomp: 14 (https://510kreport.com/company/medcomp)
- Medcomp ( Medical Components): 3 (https://510kreport.com/company/medcomp-medical-components)
- Chf Solutions, Inc.: 2 (https://510kreport.com/company/chf-solutions)
- Cook, Inc.: 2 (https://510kreport.com/company/cook)
- Novosci Corp.: 2 (https://510kreport.com/company/novosci)
- Flexicath, Ltd.: 1 (https://510kreport.com/company/flexicath)
- Datascope Corp.: 1 (https://510kreport.com/company/datascope)
- Vasca, Inc.: 1 (https://510kreport.com/company/vasca)

## Its most-cited devices
- K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 (2001), cited by 6
- K012562: Medcomp 14.5F Double Lumen Hemodialysis Catheter (2002), cited by 5
- K974236: Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL Soft-Line Double Lumen Catheter, 20CM SB (1999), cited by 4
- K981125: Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6 (1999), cited by 4
- K121094: Medcomp Vascu-Picc & Midline Catheters (2012), cited by 4
- K003682: Medcomp Z-Cath (2001), cited by 3

## Recent decisions
- K260080: Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (Oct 9, 2026)
- K250836: 14F Duo-Flow® Side X Side Double Lumen Catheter (Aug 12, 2025)
- K141633: Pro-Picc with Valve Technology (Sep 29, 2014)
- K132880: Medcomp Power Injectable Safety Huber Needle (Jan 8, 2014)
- K131687: 6F X 60CM Triple Pro-Line CT Basic IR Set (Aug 16, 2013)
- K130687: 2F & 3F Vascu-Sheath Tearaway Introducer (Aug 15, 2013)
- K130923: 5F Dignity CT Titanium Port (Jul 31, 2013)
- K124046: Valved Tearaway Introducer Generation II (Jun 3, 2013)

Source page: https://510kreport.com/company/medical-components