510(k) Report

FDA applicant

Ecomed Solutions, LLC

Mundelein, IL3 decisions2017–20260 recalls

FDA records 3 decisions for Ecomed Solutions, LLC (Mundelein, IL) from 2017 to 2026: 3 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and DXT (Injector And Syringe, Angiographic). Since 2016 its 510(k)s took a median of 266 days from receipt to decision, against 244 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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 Ecomed Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12024: 12026 (partial year): 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Ecomed Solutions, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular2decisions
  • DXTInjector And Syringe, Angiographic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 266 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 244 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K234129Ecomed Disposable Administration SetsEcomed Solutions, LLC · 20241cites it

What has FDA decided for it lately?

  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K234129Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2024
  • K162088Ecomed Disposable Angiographic SyringesEcomed Solutions, LLC · 2017

All 3 as Ecomed Solutions, LLC →