510(k) · Decided
DecidedEkos Ultrasound Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekos Corp. · NUI Ultrasound, Infusion, System
Cleared on Apr 27, 2005 as substantially equivalent to K030637 (Ekos Corp., 2003) and 6 other predicates after a 294-day review. Its family tree reaches back 7 generations to 1990. 19 later devices descend from it.
- Decided
- Apr 27, 2005
- Review
- 294 days
- Class
- Class II
- Product code
- NUI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K904788 (1990). 18 ancestors in all. 19 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 6 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 5 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 4 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 3 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 2 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 1 generation backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- This deviceK041826 Ekos Ultrasound Infusion SystemEkos Corp. · 2005
- Descendant · cites it directly · 18 of its ownK051225 Ekos Micro-Infusion SystemEkos Corp. · 2005
- Descendant · 2 generations on · 16 of its ownK053437 Ekos Micro-Infusion SystemEkos Corp. · 2006
- Descendant · 2 generations on · 16 of its ownK053432 Ekos Micro-Infusion SystemEkos Corp. · 2005
- Descendant · 3 generations on · 14 of its ownK062508 Neurowave Micro-Infusion SystemEkos Corp. · 2006
- Descendant · 3 generations on · 13 of its ownK062507 Micro-Infusion SystemEkos Corp. · 2006
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K051225Ekos Micro-Infusion SystemEkos Corp. · 2005 · cites it directly18descendants
- K053437Ekos Micro-Infusion SystemEkos Corp. · 2006 · 2 generations on16descendants
- K053432Ekos Micro-Infusion SystemEkos Corp. · 2005 · 2 generations on16descendants
- K062508Neurowave Micro-Infusion SystemEkos Corp. · 2006 · 3 generations on14descendants
- K062507Micro-Infusion SystemEkos Corp. · 2006 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −6 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −5 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −4 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −3 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −2 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −1 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| 0 (this device) | K041826 | Ekos Ultrasound Infusion System | Ekos Corp. | 2005 | — |
| +1 | K051225 | Ekos Micro-Infusion System | Ekos Corp. | 2005 | — |
| +2 | K053437 | Ekos Micro-Infusion System | Ekos Corp. | 2006 | — |
| +2 | K053432 | Ekos Micro-Infusion System | Ekos Corp. | 2005 | — |
| +3 | K062508 | Neurowave Micro-Infusion System | Ekos Corp. | 2006 | — |
| +3 | K062507 | Micro-Infusion System | Ekos Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
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
What was it cleared against? (7)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030637 | Ekos Peripheral Infusion SystemSummary page 1…m is substantially equivalent to other legally marketed devices. These devices include • EKOS Peripheral Infusion System (K030637) * Boston Scientific Corporation: Magic Infusion Catheter (K923368 & K023351)… | 2003 |
| * | K923368 | Magic Infusion CatheterSummary page 1…• EKOS Peripheral Infusion System (K030637) * Boston Scientific Corporation: Magic Infusion Catheter (K923368 & K023351) * Boston Scientific Corporation: Renegade Hi-Flo Microcatheter (KO… | 1993 |
| * | K023351 | Magic Infusion CatheterSummary page 1…• EKOS Peripheral Infusion System (K030637) * Boston Scientific Corporation: Magic Infusion Catheter (K923368 & K023351) * Boston Scientific Corporation: Renegade Hi-Flo Microcatheter (KO00177)… | 2003 |
| * | K000177 | Renegade HI-Flo Microcatheter | 2000 |
| * | K960806 | Turbo TrackerSummary page 1…i-Flo Microcatheter (KO00177) * Boston Scientific Corporation Turbo-Tracker Microcatheter (K960806) * BioSphere Medical EmboCath Hydrophilic Infusion Catheter (K003105)… | 1996 |
| * | K003105 | Biosphere Medical Infusion CatheterSummary page 1…racker Microcatheter (K960806) * BioSphere Medical EmboCath Hydrophilic Infusion Catheter (K003105) * Spencer Technologies TCD 1 OM Transcranial Doppler (K002533) Perf… | 2001 |
| * | K002533 | TCD 100M, PWD13 TransducerSummary page 2…Infusion Catheter (K003105) * Spencer Technologies TCD 1 OM Transcranial Doppler (K002533) Performance: EKOS has conducted preclinical bench and animal studies with the EKOS Micro-Infusion System. Thes… | 2000 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051225 | Ekos Micro-Infusion System | 2005 | 18 |
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 15 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 6 of the 18 ancestors have a recall of any class.
- Of its descendants, K051225 (Ekos Corp., 2005) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K030637.
How does its category compare?
All NUI devicesNUI 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
MAUDE reports naming product code NUI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
https://510kreport.com/device/K041826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041826: Ekos Ultrasound 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/K041826
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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