510(k) Report

510(k) · Decided

Decided

Neurowave Micro-Infusion System

K062508510(k) SpecialDecided Dec 5, 200699-day reviewClass II21 CFR 870.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ekos Corp. · NUI Ultrasound, Infusion, System

Cleared on Dec 5, 2006 as substantially equivalent to K060084 (Ekos Corp., 2006) and 2 other predicates after a 99-day review. Its family tree reaches back 13 generations to 1990. 14 later devices descend from it.

Decided
Dec 5, 2006
Review
99 days
Class
Class II
Product code
NUI
Recalls
None
Predicates
3

Its longest line of descent runs back 13 generations to K904788 (1990). 34 ancestors in all. 14 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 4 other ancestors2003: 2 other ancestors2001: 1 other ancestor2000: 2 other ancestors1996: 2 other ancestors1993: 3 other ancestors1995: 1 other ancestor1999: 2 other ancestors1997: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor2008: 3 descendants cleared2007: 1 descendant cleared2011: 1 descendant cleared2019: 3 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2020: 2 descendants cleared2026: 2 descendants clearedK904788 · Mewissen Catheter · Boston Scientific Corp · 1990K974067 · Fountain Infusion Catheter and Occluding Guide Wire · Merit Medical Systems, Inc. · 1998 · recalledK981417 · Squirt Fluid Delivery System · Merit Medical Systems, Inc. · 1998K013635 · Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length) · Bacchus Vascular, Inc. · 2002K021958 · Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM Catheter Length 10CM Infusion H · Bacchus Vascular, Inc. · 2002 · recalledK023514 · Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length) · Bacchus Vascular, Inc. · 2002 · recalled×2: 2 generations cleared close together, K030637 (2003), K033214 (2003) ×2: 2 generations cleared close together, K041629 (2004), K042456 (2004) ×2: 2 generations cleared close together, K051319 (2005), K052071 (2005) K060084 · Lysus Infusion System · Ekos Corp. · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 6 other ancestors5 generations back: 2 other ancestors6 generations back: 4 other ancestors7 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 5 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K060084 · Lysus Infusion System · Ekos Corp. · 2006K052071 · Lysus Infusion System · Ekos Corp. · 2005K051319 · Lysus Infusion System · Ekos Corp. · 2005K042456 · Lysus Infusion System · Ekos Corp. · 2004 · recalledK041629 · Lysus Infusion System · Ekos Corp. · 2004K033214 · Ekos Peripheral Infusion System · Ekos Corp. · 2003K030637 · Ekos Peripheral Infusion System · Ekos Corp. · 2003K023514 · Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length) · Bacchus Vascular, Inc. · 2002 · recalledK021958 · Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM Catheter Length 10CM Infusion H · Bacchus Vascular, Inc. · 2002 · recalledK013635 · Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length) · Bacchus Vascular, Inc. · 2002K981417 · Squirt Fluid Delivery System · Merit Medical Systems, Inc. · 1998K974067 · Fountain Infusion Catheter and Occluding Guide Wire · Merit Medical Systems, Inc. · 1998 · recalledK904788 · Mewissen Catheter · Boston Scientific Corp · 1990−10−50+5
  1. Root · 13 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
  2. 9 generations between
  3. 3 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
  4. 2 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
  5. 1 generation backK060084 Lysus Infusion SystemEkos Corp. · 2006
  6. This deviceK062508 Neurowave Micro-Infusion SystemEkos Corp. · 2006
  7. Descendant · cites it directly · 12 of its ownK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
  8. Descendant · cites it directly · 11 of its ownK080392 EndoWave Infusion SystemEkos Corp. · 2008
  9. Descendant · cites it directly · 11 of its ownK073166 Endowave Infusion SystemEkos Corp. · 2008
  10. Descendant · 2 generations on · 10 of its ownK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
  11. Descendant · 3 generations on · 9 of its ownK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
Show all 13 generations
  1. Root · 13 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
  2. 12 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
  3. 11 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
  4. 10 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
  5. 9 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
  6. 8 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
  7. 7 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  8. 6 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  9. 5 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
  10. 4 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
  11. 3 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
  12. 2 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
  13. 1 generation backK060084 Lysus Infusion SystemEkos Corp. · 2006
  14. This deviceK062508 Neurowave Micro-Infusion SystemEkos Corp. · 2006

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2007: 12008: 32011: 12019: 32020: 22021: 12024: 12026: 2
2007high 3 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all
  • K063620Ekos Micro-Infusion SystemEkos Corp. · 2007 · cites it directly12descendants
  • K080392EndoWave Infusion SystemEkos Corp. · 2008 · cites it directly11descendants
  • K073166Endowave Infusion SystemEkos Corp. · 2008 · cites it directly11descendants
  • K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · 2 generations on10descendants
  • K111705Ekosonic Endovascular SystemEkos Corporation · 2011 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K904788Mewissen CatheterBoston Scientific Corp1990—
−12K974067Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.199823
−11K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc.1998—
−10K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…Bacchus Vascular, Inc.2002—
−9K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…Bacchus Vascular, Inc.20021
−8K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc.20021
−7K030637Ekos Peripheral Infusion SystemEkos Corp.2003—
−6K033214Ekos Peripheral Infusion SystemEkos Corp.2003—
−5K041629Lysus Infusion SystemEkos Corp.2004—
−4K042456Lysus Infusion SystemEkos Corp.20043
−3K051319Lysus Infusion SystemEkos Corp.2005—
−2K052071Lysus Infusion SystemEkos Corp.2005—
−1K060084Lysus Infusion SystemEkos Corp.2006—
0 (this device)K062508Neurowave Micro-Infusion SystemEkos Corp.2006—
+1K063620Ekos Micro-Infusion SystemEkos Corp.2007—
+1K080392EndoWave Infusion SystemEkos Corp.2008—
+1K073166Endowave Infusion SystemEkos Corp.2008—
+2K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.20085
+3K111705Ekosonic Endovascular SystemEkos Corporation20115

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199330
199410
199510
199620
199710
199920
200020
200110
200320
200540
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200830
201110
201930
202020
202110
202410
202620
FIG. 1 — Lineage of K062508, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NUI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K060084Lysus Infusion System
Summary page 1
…NeuroWave Micro-Infusion System Name of Predicate Device: NeuroWave Micro-Infusion System 510(k) Reference No.: K060084 K053437 K053432 Device Description The system…
Ekos Corp.2006—
*K053437Ekos Micro-Infusion System
Summary page 1
…stem Name of Predicate Device: NeuroWave Micro-Infusion System 510(k) Reference No.: K060084 K053437 K053432 Device Description The system consists of a disposable infusion/ultrasound cath…
Ekos Corp.2006—
*K053432Ekos Micro-Infusion System
Summary page 1
…uroWave Micro-Infusion System 510(k) Reference No.: K060084 K053437 K053432 Device Description The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and control…
Ekos Corp.2005—

Also cleared against K060084: 2 other devices →

What descends from it? (14)

See all 14

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063620Ekos Micro-Infusion SystemEkos Corp.200712
K080392EndoWave Infusion SystemEkos Corp.200811
K073166Endowave Infusion SystemEkos Corp.200811

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 6 months on median.
  • 8 of the 34 ancestors have a recall of any class.
  • Of its descendants, K063620 (Ekos Corp., 2007) has gone furthest, with 12 descendants of its own.
  • 2 other devices also cite its predicate K060084.

How does its category compare?

All NUI devices

NUI Ultrasound, Infusion, System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NUI

FDA has decided no NUI device since 2007.

Median 510(k) review, days · NUI

Too few NUI 510(k)s in any year since 2007 to give a median.

Recalls per year · NUI

No recall names NUI since 2007.

Adverse event reports per year · NUI

1in 2014

2007: 22014: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code NUI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K060084

2 other devices cite the same predicate.

  • K072507Endowave Infusion SystemEkos Corp. · 20073 recalls
  • K062507Micro-Infusion SystemEkos Corp. · 2006

More from Ekos Corp.

23 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in NUI

The NUI category page

  • K053437Ekos Micro-Infusion SystemEkos Corp. · 2006
  • K051225Ekos Micro-Infusion SystemEkos Corp. · 2005
  • K041826Ekos Ultrasound Infusion SystemEkos Corp. · 2005

https://510kreport.com/device/K062508 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062508: Neurowave Micro-Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062508

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026