510(k) Report

FDA applicant

E-Med Corp.

Mchenry, IL3 decisions1979–19980 recalls

FDA records 3 decisions for E-Med Corp. (Mchenry, IL) from 1979 to 1998: 3 510(k) clearances. Most are in product codes KMK (Device, Intravascular Catheter Securement) and KRA (Catheter, Continuous Flush). Its devices cite 2 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 E-Med Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for E-Med Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like E-Med Corp.’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?

  • KMKDevice, Intravascular Catheter Securement1decision
  • KRACatheter, Continuous Flush1decision
  • NADDressing, Wound, Occlusive1decision

Whose devices does it build on?

Its devices cite 2 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.

  • K971619Microfuse Membrane Infusion CatheterE-Med Corp. · 19981cites it

What has FDA decided for it lately?

  • K971619Microfuse Membrane Infusion CatheterE-Med Corp. · 1998
  • K843200Site StripE-Med Corp. · 1985
  • K792049I.V. StripE-Med Corp. · 1979

All 3 as E-Med Corp. →