510(k) Report

FDA applicant

Medcomp

Harleysville, PA40 decisions1982–201417 recalls

FDA records 40 decisions for Medcomp (Harleysville, PA) from 1982 to 2014: 40 510(k) clearances. Most are in product codes MSD (Catheter, Hemodialysis, Implanted) and LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 65 predicates, 25 of them its own earlier devices. 17 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Medcomp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 22008: 22009: 62010: 22013: 12014: 1
2007high 6 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

9in 2018

2008: 12010: 12011: 12012: 42015: 12018: 9
2007high 9 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medcomp by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MSDCatheter, Hemodialysis, Implanted13decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days11decisions
  • DYBIntroducer, Catheter4decisions
  • LFJCatheter, Subclavian3decisions
  • NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted2decisions
  • DQXWire, Guide, Catheter2decisions

Also: KNT (1), NFK (1), FPA (1), LJT (1), FOZ (1).

Whose devices does it build on?

Its devices cite 65 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 83 times; 25 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091953Pro-PiccMedcomp · 20098cite it
  • K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached)Medcomp · 20078cite it
  • K053345Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp · 20067cite it
  • K020465Medcomp Ash Split-Cath IIMedcomp · 20026cite it
  • K091586Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp · 20095cite it
  • K972207Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMMedcomp · 19985cite it

What has FDA decided for it lately?

  • K130889Split Cath RGMedcomp · 2014
  • K123292T3Medcomp · 2013
  • K1029662.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccMedcomp · 2010
  • K091954Micro-Stick SetMedcomp · 2010
  • K092347Pro-Picc CTMedcomp · 2009
  • K091953Pro-PiccMedcomp · 2009
  • K090394Valved Tearway IntroducerMedcomp · 2009
  • K091586Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp · 2009

All 40 as Medcomp →

What has been recalled?

17 recalls linked to its devices; the latest:

  • K022570REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is…Feb 23, 2018Class II
  • K02257012F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The…Feb 23, 2018Class II
  • K022570CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair…Feb 23, 2018Class II
  • K02257012F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product…Feb 23, 2018Class II
  • K022570CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair…Feb 23, 2018Class II
  • K02257012F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product…Feb 23, 2018Class II

Other applicant names beginning “Medcomp”

FDA records each applicant name separately; these may or may not be the same firm.

Medcomp ( Medical Components) 13Medcomp Technologies, Inc. 5Medcomp (Dba Medical Components, Inc.) 3