510(k) Report

FDA applicant

Concert Medical, LLC

Norwell, MA3 decisions2009–20160 recalls

FDA records 3 decisions for Concert Medical, LLC (Norwell, MA) from 2009 to 2016: 3 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and FRN (Pump, Infusion). Its devices cite 5 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, cardiovascular panel, where it files most

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

FDA decisions per year

2in 2016

2009: 12016: 2
2009high 2 (2016) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Concert Medical, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Concert Medical, LLC’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?

  • DQXWire, Guide, Catheter2decisions
  • FRNPump, Infusion1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 20161cites it
  • K153397S-Wire Guidewire SystemConcert Medical, LLC · 20161cites it

What has FDA decided for it lately?

  • K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016
  • K153397S-Wire Guidewire SystemConcert Medical, LLC · 2016
  • K090193Conductor Coronary GuidewireConcert Medical, LLC · 2009

All 3 as Concert Medical, LLC →