510(k) · Cleared
ClearedEkos Micro-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 Jan 6, 2006 as substantially equivalent to K050563 (Ekos Corp., 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 10 generations to 1990. 16 later devices descend from it.
- Decided
- Jan 6, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- NUI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K904788 (1990). 22 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 6 generations between
- 3 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 2 generations backK050563 Ekos Peripheral Infusion SystemEkos Corp. · 2005
- 1 generation backK051225 Ekos Micro-Infusion SystemEkos Corp. · 2005
- This deviceK053437 Ekos Micro-Infusion SystemEkos Corp. · 2006
- Descendant · cites it directly · 14 of its ownK062508 Neurowave Micro-Infusion SystemEkos Corp. · 2006
- Descendant · cites it directly · 13 of its ownK062507 Micro-Infusion SystemEkos Corp. · 2006
- Descendant · cites it directly · 12 of its ownK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- Descendant · 2 generations on · 11 of its ownK080392 EndoWave Infusion SystemEkos Corp. · 2008
- Descendant · 2 generations on · 11 of its ownK073166 Endowave Infusion SystemEkos Corp. · 2008
Show all 10 generations
- Root · 10 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 9 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 8 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 7 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 6 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 5 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 4 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 3 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 2 generations backK050563 Ekos Peripheral Infusion SystemEkos Corp. · 2005
- 1 generation backK051225 Ekos Micro-Infusion SystemEkos Corp. · 2005
- This deviceK053437 Ekos Micro-Infusion SystemEkos Corp. · 2006
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K062508Neurowave Micro-Infusion SystemEkos Corp. · 2006 · cites it directly14descendants
- K062507Micro-Infusion SystemEkos Corp. · 2006 · cites it directly13descendants
- K063620Ekos Micro-Infusion SystemEkos Corp. · 2007 · cites it directly12descendants
- K080392EndoWave Infusion SystemEkos Corp. · 2008 · 2 generations on11descendants
- K073166Endowave Infusion SystemEkos Corp. · 2008 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −9 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −8 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −7 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −6 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −5 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −4 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −3 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −2 | K050563 | Ekos Peripheral Infusion System | Ekos Corp. | 2005 | — |
| −1 | K051225 | Ekos Micro-Infusion System | Ekos Corp. | 2005 | — |
| 0 (this device) | K053437 | Ekos Micro-Infusion System | Ekos Corp. | 2006 | — |
| +1 | K062508 | Neurowave Micro-Infusion System | Ekos Corp. | 2006 | — |
| +1 | K062507 | Micro-Infusion System | Ekos Corp. | 2006 | — |
| +1 | K063620 | Ekos Micro-Infusion System | Ekos Corp. | 2007 | — |
| +2 | K080392 | EndoWave Infusion System | Ekos Corp. | 2008 | — |
| +2 | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K050563 | Ekos Peripheral Infusion SystemSummary page 1…System Name of Predicate Predicate Device 510(k) Reference Nos. Device EKOS Peripheral Infusion System K050563 EKOS Micro- Infusion System K051225 Device Description The system consists of a dis… | 2005 |
| * | K051225 | Ekos Micro-Infusion SystemSummary page 1…510(k) Reference Nos. Device EKOS Peripheral Infusion System K050563 EKOS Micro- Infusion System K051225 Device Description The system consists of a disposable infusion/ultrasound catheter and an instrument… | 2005 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 months on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K062508 (Ekos Corp., 2006) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K050563.
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 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.
https://510kreport.com/device/K053437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053437: Ekos 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/K053437
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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