510(k) Report

FDA applicant

Medcomp (Dba Medical Components, Inc.)

Harleysville, PA3 decisions2017–20170 recalls

FDA records 3 decisions for Medcomp (Dba Medical Components, Inc.) (Harleysville, PA) in 2017: 3 510(k) clearances. Most are in product codes PTI (Non-Coring (Huber) Needle) and MSD (Catheter, Hemodialysis, Implanted). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FDA decisions per year

3in 2017

2017: 3
2017high 3 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

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

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Other applicant names beginning “Medcomp”

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