510(k) Report

510(k) · Cleared

Cleared

Omniwave Endovascular System

K071762510(k) TraditionalCleared Sep 27, 200790-day reviewClass II21 CFR 870.5150

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

Omnisonics Medical Technologies · QEY Mechanical Thrombolysis Catheter

Cleared on Sep 27, 2007 as substantially equivalent to K050147 (Bacchus Vascular, Inc., 2005) and 3 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1990. 1 later device descends from it.

Decided
Sep 27, 2007
Review
90 days
Class
Class II
Product code
QEY
Recalls
None
Predicates
4

Its longest line of descent runs back 9 generations to K904788 (1990). 58 ancestors in all, the oldest K873004 (1987). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 3 other ancestors2004: 4 other ancestors2003: 5 other ancestors2002: 7 other ancestors2000: 5 other ancestors1999: 4 other ancestors1998: 2 other ancestors1997: 4 other ancestors2001: 4 other ancestors1996: 2 other ancestors1995: 3 other ancestors1994: 2 other ancestors1993: 2 other ancestors1987: 1 other ancestor1991: 1 other ancestor2008: 1 descendant clearedK904788 · Mewissen Catheter · Boston Scientific Corp · 1990×2: 2 generations cleared close together, K974067 (1998), K981417 (1998) ×3: 3 generations cleared close together, K013635 (2002), K021958 (2002), K023514 (2002) ×2: 2 generations cleared close together, K030637 (2003), K033214 (2003) K050563 · Ekos Peripheral Infusion System · Ekos Corp. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 13 other ancestors4 generations back: 19 other ancestors5 generations back: 8 other ancestors 1 generation forward: 1 descendant K050563 · Ekos Peripheral Infusion System · Ekos Corp. · 2005K033214 · 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 · 1990−50
  1. Root · 9 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
  2. 5 generations between
  3. 3 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  4. 2 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  5. 1 generation backK050563 Ekos Peripheral Infusion SystemEkos Corp. · 2005
  6. This deviceK071762 Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007
  7. Descendant · cites it directly · 0 of its ownK083335 Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008
Show all 9 generations
  1. Root · 9 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
  2. 8 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
  3. 7 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
  4. 6 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
  5. 5 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
  6. 4 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
  7. 3 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  8. 2 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  9. 1 generation backK050563 Ekos Peripheral Infusion SystemEkos Corp. · 2005
  10. This deviceK071762 Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K904788Mewissen CatheterBoston Scientific Corp1990—
−8K974067Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.199823
−7K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc.1998—
−6K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…Bacchus Vascular, Inc.2002—
−5K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…Bacchus Vascular, Inc.20021
−4K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc.20021
−3K030637Ekos Peripheral Infusion SystemEkos Corp.2003—
−2K033214Ekos Peripheral Infusion SystemEkos Corp.2003—
−1K050563Ekos Peripheral Infusion SystemEkos Corp.2005—
0 (this device)K071762Omniwave Endovascular SystemOmnisonics Medical Technologies2007—
+1K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
199320
199420
199530
199620
199740
199820
199940
200050
200140
200270
200350
200440
200530

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K071762, 1990–2008Source: 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 QEY? 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 QEY device

  1. #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K050147Trellis-8 Peripheral Infusion System
Summary page 5
…iwave Endovascular System Classification Name: CFR §870.1210, Catheter, Continuous Flush Predicate Devices: 1. Bacchus Trellis®-8 Peripheral Infusion System - K050147 2. KPS Rinspiration TM System - K050130 3. EKOS Lysus® Infusion Catheter System - K050563 4. Omnisonics Resolution® Endo…
Bacchus Vascular, Inc.2005—
*K050130Kerberos Proximal Solutions Rispiration System
Summary page 5
…ame: CFR §870.1210, Catheter, Continuous Flush Predicate Devices: 1. Bacchus Trellis®-8 Peripheral Infusion System - K050147 2. KPS Rinspiration TM System - K050130 3. EKOS Lysus® Infusion Catheter System - K050563 4. Omnisonics Resolution® Endovascular System - K052428 Device Descripti…
Kerberos Proximal Solutions, Inc.2005—
*K050563Ekos Peripheral Infusion System
Summary page 5
…Predicate Devices: 1. Bacchus Trellis®-8 Peripheral Infusion System - K050147 2. KPS Rinspiration TM System - K050130 3. EKOS Lysus® Infusion Catheter System - K050563 4. Omnisonics Resolution® Endovascular System - K052428 Device Description: The Omniwave Endovascular System is comprised of…
Ekos Corp.2005—
*K052428Resolution Endovascular System
Summary page 5
…usion System - K050147 2. KPS Rinspiration TM System - K050130 3. EKOS Lysus® Infusion Catheter System - K050563 4. Omnisonics Resolution® Endovascular System - K052428 Device Description: The Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and…
Omnisonics Medical Technologies2005—

Also cleared against K050147: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080

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 17 years and passes through 5 companies; a new generation was cleared every 8 months on median.
  • 10 of the 58 ancestors have a recall of any class.
  • Of its descendants, K083335 (Omnisonics Medical Technologies, 2008) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K050147.

How does its category compare?

All QEY devices

QEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · QEY

1in 2024

2007: 52008: 42011: 12013: 12014: 12015: 12016: 22017: 32018: 12019: 52020: 32021: 32022: 12023: 22024: 12026 (partial year): 2
2007high 5 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEY

62in 2021

2007: 28 days median2008: 54 days median2017: 144 days median2019: 91 days median2020: 158 days median2021: 62 days median
2007high 158 (2020) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEY

1in 2023

2022: 12023: 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QEY

5in 2025

2023: 12024: 12025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code QEY, 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
200752800
200845400
20090—00
20100—00
20111—00
20120—00
20131—00
20141—00
20151—00
20162—00
2017314400
20181—00
201959100
2020315800
202136200
20221—10
20232—11
20241—01
20250—05
20262—0—

What is it indicated for?

The Omniwave Endovascular System is indicated for use in the infusion of

physician specified fluids, including thrombolytics, into the peripheral vasculature

and for removal of thrombi from the peripheral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K050147

2 other devices cite the same predicate.

  • K130904Trellis-8 Peripheral Infusion SystemCovidien · 20131 Class I recall
  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 20071 Class I recall

More from Omnisonics Medical Technologies

8 FDA decisions under this applicant name. See the company

  • K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008
  • K052428Resolution Endovascular SystemOmnisonics Medical Technologies · 2005
  • K041705Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies · 2004
  • K003824Omnisonics Ultrasonic Surgery System, Model StiOmnisonics Medical Technologies · 2001
  • K993628Omnisonics Ultrasonic ProbesOmnisonics Medical Technologies · 1999

Recent decisions in QEY

The QEY category page

  • K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc. · 2026
  • K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc. · 2026
  • K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
  • K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc. · 2023
  • K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc. · 2023

https://510kreport.com/device/K071762 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071762: Omniwave Endovascular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071762

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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