# Medcomp ( Medical Components)

- Location (FDA's records): Harleysville, PA
- FDA decisions: 13 (2009–2017): 13 510(k) clearances
- Names in FDA's records: Medcomp ( Medical Components) (7); Medcomp (Medical Components, Inc.) (6)
- Product codes: LJS (6), LJT (3), DYB (2), DRE (1), PTI (1)
- 510(k) review time since 2016: median 127 days, against 108 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 16 (1 its own); citations of its devices by later devices: 13 (1 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medcomp: 5 (https://510kreport.com/company/medcomp)
- Medical Components, Inc.: 3 (https://510kreport.com/company/medical-components)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Romedex International Srl: 1 (https://510kreport.com/company/romedex-international)
- Martech Medical Products, Inc.: 1 (https://510kreport.com/company/martech-medical-products)
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)
- Alva Medical, Inc.: 1 (https://510kreport.com/company/alva-medical)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)

## Firms that cite its devices most
- Medcomp (Dba Medical Components, Inc.): 2 (https://510kreport.com/company/medcomp-dba-medical-components)
- Medical Components, Inc.: 2 (https://510kreport.com/company/medical-components)
- Medical Components, Inc. (dba MedComp): 2 (https://510kreport.com/company/medical-components-dba-medcomp)
- Medron, Inc.: 1 (https://510kreport.com/company/medron)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Health Line International Corporation: 1 (https://510kreport.com/company/health-line-international)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)

## Its most-cited devices
- K141151: CT Midline (2014), cited by 3
- K140799: Celerity Sysyem (2014), cited by 2
- K162389: Medcomp Vessel Dilator (2017), cited by 2
- K093309: Pro-Line CT (Basic Tray) Model MR28036101 (2009), cited by 2
- K143238: C3 Wave (2015), cited by 1
- K132498: Valved Tearaway Introducer Generation II (2013), cited by 1

## Recent decisions
- K171931: Celerity ECG Cable Accessory Pack (Oct 26, 2017)
- K162389: Medcomp Vessel Dilator (Jun 1, 2017)
- K162271: Pro-Lock CT Safety Infusion Set (Apr 26, 2017)
- K153238: Dignity Dual Port (Mar 15, 2016)
- K153246: PTFE Super Sheath Introducer 2.1 (Feb 12, 2016)
- K143238: C3 Wave (Apr 24, 2015)
- K141151: CT Midline (Jul 8, 2014)
- K140799: Celerity Sysyem (Jun 13, 2014)

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