510(k) Report

FDA applicant

Medical Components, Inc. (dba MedComp)

Harleysville, PA9 decisions2017–20231 recall

FDA records 9 decisions for Medical Components, Inc. (dba MedComp) (Harleysville, PA) from 2017 to 2023: 9 510(k) clearances. Most are in product codes NIE (Catheter, Hemodialysis, Triple Lumen…) and MSD (Catheter, Hemodialysis, Implanted). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Medical Components, Inc (Dba Medcomp_”.

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 Medical Components, Inc. (dba MedComp)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 22018: 32019: 12020: 22023: 1
2017high 3 (2018) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2017high 1 (2018) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Medical Components, Inc. (dba MedComp) by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medical Components, Inc. (dba MedComp)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted3decisions
  • MSDCatheter, Hemodialysis, Implanted2decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2decisions
  • MPBCatheter, Hemodialysis, Non-Implanted1decision
  • PNDMidline Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 133 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K170934C3 Wave SystemMedical Components, Inc (Dba Medcomp_ · 20172cite it
  • K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 20191cites it
  • K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp) · 20201cites it
  • K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term…Medical Components, Inc. (dba MedComp) · 20181cites it

What has FDA decided for it lately?

  • K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp) · 2023
  • K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp) · 2020
  • K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp) · 2020
  • K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019
  • K18117512F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2018
  • K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term…Medical Components, Inc. (dba MedComp) · 2018
  • K180567C3 Wave SystemMedical Components, Inc. (dba MedComp) · 2018
  • K170934C3 Wave SystemMedical Components, Inc (Dba Medcomp_ · 20171 recall

All 8 as Medical Components, Inc. (dba MedComp) →The one decision as Medical Components, Inc (Dba Medcomp_ →

What has been recalled?

1 recall linked to its devices; the latest:

  • K170934C3 Wave App, v. 2.0.5Oct 1, 2018Class II