510(k) Report

FDA applicant

Ekos Corp.

Bothell, WA25 decisions2003–202013 recalls

FDA records 25 decisions for Ekos Corp. (Bothell, WA) from 2003 to 2020: 25 510(k) clearances. Most are in product codes QEY (Mechanical Thrombolysis Catheter) and NUI (Ultrasound, Infusion, System). Its devices cite 64 predicates, 39 of them its own earlier devices. 13 recalls are linked to its devices.

FDA’s records also spell it “Ekos Corporation”.

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 Ekos Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 32008: 32011: 12020: 1
2007high 3 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2022

2007: 12008: 32012: 12013: 12015: 12016: 22022: 1
2007high 3 (2008) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Ekos 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?

  • QEYMechanical Thrombolysis Catheter19decisions
  • NUIUltrasound, Infusion, System4decisions
  • KRACatheter, Continuous Flush1decision
  • DRACatheter, Steerable1decision

Whose devices does it build on?

Its devices cite 64 predicates; 39 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 44 times; 39 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.

  • K050563Ekos Peripheral Infusion SystemEkos Corp. · 20054cite it
  • K053437Ekos Micro-Infusion SystemEkos Corp. · 20063cite it
  • K053432Ekos Micro-Infusion SystemEkos Corp. · 20053cite it
  • K042456Lysus Infusion SystemEkos Corp. · 20043cite it
  • K060084Lysus Infusion SystemEkos Corp. · 20063cite it
  • K062508Neurowave Micro-Infusion SystemEkos Corp. · 20063cite it

What has FDA decided for it lately?

  • K200648EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation · 20201 recall
  • K111705Ekosonic Endovascular SystemEkos Corporation · 20115 recalls
  • K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 20085 recalls
  • K080392EndoWave Infusion SystemEkos Corp. · 2008
  • K073166Endowave Infusion SystemEkos Corp. · 2008
  • K072507Endowave Infusion SystemEkos Corp. · 20073 recalls
  • K071933Endowave Infusion SystemEkos Corp. · 2007
  • K063620Ekos Micro-Infusion SystemEkos Corp. · 2007

All 23 as Ekos Corp. →All 2 as Ekos Corporation →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K162771EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a…Oct 13, 2022Class II
  • K081467EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery CatheterAug 9, 2016Class II
  • K081467EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main…Jan 21, 2016Class II
  • K081467The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic…Jun 24, 2015Class II
  • K081467The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585…Oct 2, 2013Class II
  • K081467EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124…May 24, 2012Class II