510(k) Report

FDA applicant

Mhc Medical Products, LLC

Naples, FL3 decisions2010–20182 recalls

FDA records 3 decisions for Mhc Medical Products, LLC (Naples, FL) from 2010 to 2018: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). Its devices cite 6 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Mhc Medical Products”.

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 Mhc Medical Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2010: 12011: 12018: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2018

2018: 2
2010high 2 (2018) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Mhc Medical Products, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • FMFSyringe, Piston1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K163578EasyTouch Safety Pen NeedleMhc Medical Products, LLC · 20181cites it

What has FDA decided for it lately?

  • K163578EasyTouch Safety Pen NeedleMhc Medical Products, LLC · 2018
  • K112789Easy TouchMhc Medical Products, LLC · 20112 recalls
  • K102178Easy TouchMhc Medical Products · 2010

All 2 as Mhc Medical Products, LLC →The one decision as Mhc Medical Products →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K112789EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR…Apr 6, 2018Class II
  • K112789EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR…Apr 6, 2018Class II