510(k) · Decided
DecidedEndowave Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekos Corp. · KRA Catheter, Continuous Flush
Cleared on Apr 22, 2008 as substantially equivalent to K071933 (Ekos Corp., 2007) and 7 other predicates after a 165-day review. Its family tree reaches back 15 generations to 1990. 11 later devices descend from it.
- Decided
- Apr 22, 2008
- Review
- 165 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 15 generations to K904788 (1990). 45 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 11 generations between
- 3 generations backK060084 Lysus Infusion SystemEkos Corp. · 2006
- 2 generations backK062507 Micro-Infusion SystemEkos Corp. · 2006
- 1 generation backK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- This deviceK073166 Endowave Infusion SystemEkos Corp. · 2008
- Descendant · cites it directly · 10 of its ownK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
- Descendant · 2 generations on · 9 of its ownK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- Descendant · 3 generations on · 8 of its ownK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK192864 UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK241851 Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
Show all 15 generations
- Root · 15 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 14 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 13 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 12 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 11 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 10 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 9 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 8 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 7 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 6 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 5 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 4 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 3 generations backK060084 Lysus Infusion SystemEkos Corp. · 2006
- 2 generations backK062507 Micro-Infusion SystemEkos Corp. · 2006
- 1 generation backK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- This deviceK073166 Endowave Infusion SystemEkos Corp. · 2008
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · cites it directly10descendants
- K111705Ekosonic Endovascular SystemEkos Corporation · 2011 · 2 generations on9descendants
- K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc. · 2019 · 3 generations on8descendants
- K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020 · 4 generations on2descendants
- K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −14 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −13 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −12 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −11 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −10 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −9 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −8 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −7 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −6 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −5 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −4 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −3 | K060084 | Lysus Infusion System | Ekos Corp. | 2006 | — |
| −2 | K062507 | Micro-Infusion System | Ekos Corp. | 2006 | — |
| −1 | K063620 | Ekos Micro-Infusion System | Ekos Corp. | 2007 | — |
| 0 (this device) | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
| +1 | K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | 2008 | 5 |
| +2 | K111705 | Ekosonic Endovascular System | Ekos Corporation | 2011 | 5 |
| +3 | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter… | Thrombolex, Inc. | 2019 | — |
| +4 | K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020 | — |
| +4 | K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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 KRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K071933 | Endowave Infusion SystemSummary page 1…tially equivalent to other legally marketed devices. These devices include I. EKOS EndoWave Infusion System (EKOS Corporation,K071933, K072507) 2. EKOS NeuroWave Infusion System (EKOS Corporation,K062508,… | 2007 |
| * | K072507 | Endowave Infusion SystemSummary page 1…legally marketed devices. These devices include I. EKOS EndoWave Infusion System (EKOS Corporation,K071933, K072507) 2. EKOS NeuroWave Infusion System (EKOS Corporation,K062508, K063620)… | 2007 |
| * | K062508 | Neurowave Micro-Infusion SystemSummary page 1…I. EKOS EndoWave Infusion System (EKOS Corporation,K071933, K072507) 2. EKOS NeuroWave Infusion System (EKOS Corporation,K062508, K063620) 3. Edwards Swan-Ganz Standard Thermodilution Pulmonary Artery… | 2006 |
| * | K063620 | Ekos Micro-Infusion SystemSummary page 1…EKOS Corporation,K071933, K072507) 2. EKOS NeuroWave Infusion System (EKOS Corporation,K062508, K063620) 3. Edwards Swan-Ganz Standard Thermodilution Pulmonary Artery Catheter, (Edward… | 2007 |
| * | K014054 | Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon MaterialSummary page 1…K063620) 3. Edwards Swan-Ganz Standard Thermodilution Pulmonary Artery Catheter, (Edwards Lifesciences, K014054) 4. Z-Med II-X, (NuMED, Inc., K003052,K011557, K030589) Performance: EKOS has conducted preclinic… | 2002 |
| * | K003052 | Numed Tyshak II and Z-Med II PTV CathetersSummary page 1…wan-Ganz Standard Thermodilution Pulmonary Artery Catheter, (Edwards Lifesciences, K014054) 4. Z-Med II-X, (NuMED, Inc., K003052,K011557, K030589) Performance: EKOS has conducted preclinical bench and animal studies with the EndoWav… | 2000 |
| * | K011557 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersSummary page 1…Standard Thermodilution Pulmonary Artery Catheter, (Edwards Lifesciences, K014054) 4. Z-Med II-X, (NuMED, Inc., K003052,K011557, K030589) Performance: EKOS has conducted preclinical bench and animal studies with the EndoWaveTM Infu… | 2001 |
| * | K030589 | Modification to Numed Tyshak II and Z-Med II PTV CathetersSummary page 1…Thermodilution Pulmonary Artery Catheter, (Edwards Lifesciences, K014054) 4. Z-Med II-X, (NuMED, Inc., K003052,K011557, K030589) Performance: EKOS has conducted preclinical bench and animal studies with the EndoWaveTM Infusion Syst… | 2003 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | 2008 | 10 |
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 18 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 10 of the 45 ancestors have a recall of any class.
- Of its descendants, K081467 (Ekos Corp., 2008) has gone furthest, with 10 descendants of its own.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The EndoWaveTM Infusion System is intended for the infusion of solutions into the pulmonary arteries.
The safety and effectiveness of the EKOS EndoWaveTM Infusion system for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073166 · printed Nov 3, 2026
Cite this page
510(k) Report. “K073166: Endowave Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K073166
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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