510(k) Report

FDA applicant

Coramed Technologies, LLC

Niles, IL2 decisions2015–20150 recalls

FDA records 2 decisions for Coramed Technologies, LLC (Niles, IL) in 2015: 2 510(k) clearances. Most are in product codes JOZ (System, Automated Platelet Aggregation) and JPA (System, Multipurpose For In Vitro Coagulation…). 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, hematology panel, where it files most

How often FDA has decided Coramed Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015: 2
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Coramed Technologies, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JOZSystem, Automated Platelet Aggregation1decision
  • JPASystem, Multipurpose For In Vitro Coagulation Studies1decision

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 3 times; 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.

  • K150041CORA (Coagulation Resonance Analysis) SystemCoramed Technologies, LLC · 20153cite it

What has FDA decided for it lately?

  • K150041CORA (Coagulation Resonance Analysis) SystemCoramed Technologies, LLC · 2015
  • K140893Cora (Coagulation Resonance Analysis) System with Platelet Mapping AssayCoramed Technologies, LLC · 2015

All 2 as Coramed Technologies, LLC →