510(k) Report

FDA applicant

Medcomp ( Medical Components)

Harleysville, PA13 decisions2009–20175 recalls

FDA records 13 decisions for Medcomp ( Medical Components) (Harleysville, PA) from 2009 to 2017: 13 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and LJT (Port & Catheter, Implanted, Subcutaneous…). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Medcomp (Medical Components, Inc.)”.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

3in 2017

2009: 12011: 12013: 32014: 22015: 12016: 22017: 3
2009high 3 (2013) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2021

2016: 12017: 32021: 1
2009high 3 (2017) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Medcomp ( Medical Components) by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days6decisions
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular3decisions
  • DYBIntroducer, Catheter2decisions
  • DREDilator, Vessel, For Percutaneous Catheterization1decision
  • PTINon-Coring (Huber) Needle1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 127 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 1 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.

  • K141151CT MidlineMedcomp (Medical Components, Inc.) · 20143cite it
  • K140799Celerity SysyemMedcomp (Medical Components, Inc.) · 20142cite it
  • K162389Medcomp Vessel DilatorMedcomp ( Medical Components) · 20172cite it
  • K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components) · 20092cite it
  • K143238C3 WaveMedcomp ( Medical Components) · 20151cites it
  • K132498Valved Tearaway Introducer Generation IIMedcomp (Medical Components, Inc.) · 20131cites it

What has FDA decided for it lately?

  • K171931Celerity ECG Cable Accessory PackMedcomp (Medical Components, Inc.) · 2017
  • K162389Medcomp Vessel DilatorMedcomp ( Medical Components) · 2017
  • K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017
  • K153238Dignity Dual PortMedcomp ( Medical Components) · 2016
  • K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.) · 2016
  • K143238C3 WaveMedcomp ( Medical Components) · 2015
  • K141151CT MidlineMedcomp (Medical Components, Inc.) · 2014
  • K140799Celerity SysyemMedcomp (Medical Components, Inc.) · 20141 recall

All 7 as Medcomp ( Medical Components) →All 6 as Medcomp (Medical Components, Inc.) →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K132177Power Injectable CT Port insertion kits - Product Usage: is an implantable access device…Jan 13, 2021Class II
  • K1321778F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane CatheterNov 22, 2017Class II
  • K1321776.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter…May 25, 2017Class II
  • K1321779.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power…Feb 23, 2017Class II
  • K140799Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following…Sep 7, 2016Class II

Other applicant names beginning “Medcomp”

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

Medcomp 40Medcomp Technologies, Inc. 5Medcomp (Dba Medical Components, Inc.) 3