510(k) Report

510(k) · Cleared

Cleared

Trellis Reserve Infusion System

K032261510(k) SpecialCleared Aug 22, 200330-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

Bacchus Vascular, Inc. · QEY Mechanical Thrombolysis Catheter

Cleared on Aug 22, 2003 as substantially equivalent to K023514 (Bacchus Vascular, Inc., 2002) after a 30-day review. Its family tree reaches back 6 generations to 1990. 2 of the 17 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.

Decided
Aug 22, 2003
Review
30 days
Class
Class II
Product code
QEY
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K904788 (1990). 10 ancestors in all. 6 later devices descend from it, 1 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestor1996: 1 other ancestor2005: 1 descendant cleared2007: 2 descendants cleared, 1 with a Class I recall12013: 1 descendant cleared, 1 with a Class I recall12008: 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 3 other ancestors5 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants, 2 with a Class I recall23 generations forward: 2 descendants K023514 · 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 · 6 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
  2. 5 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
  3. 4 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
  4. 3 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
  5. 2 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
  6. 1 generation backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
  7. This deviceK032261 Trellis Reserve Infusion SystemBacchus Vascular, Inc. · 2003
  8. Descendant · cites it directly · 5 of its ownK050147 Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc. · 2005
  9. Descendant · 2 generations on · 1 of its ownK071762 Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007
  10. Descendant · 2 generations on · 1 of its ownK071664 Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · Recalled (Class I)
  11. Descendant · 2 generations on · 0 of its ownK130904 Trellis-8 Peripheral Infusion SystemCovidien · 2013 · Recalled (Class I)
  12. Descendant · 3 generations on · 0 of its ownK083335 Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12007: 22008: 22013: 1
2005high 2 (2007) · low 0 (2006)2026

Class I recalls in this family

  • K071664 Trellis-6 Peripheral Infusion System2 generations on · 2007
  • K130904 Trellis-8 Peripheral Infusion System2 generations on · 2013

Most influential descendants

Showing 5 of 6 · See all
  • K050147Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc. · 2005 · cites it directly5descendants
  • K071762Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007 · 2 generations on1descendant
  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · 2 generations on1descendant
  • K130904Trellis-8 Peripheral Infusion SystemCovidien · 2013 · 2 generations on0descendants
  • K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K904788Mewissen CatheterBoston Scientific Corp1990—
−5K974067Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.199823
−4K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc.1998—
−3K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…Bacchus Vascular, Inc.2002—
−2K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…Bacchus Vascular, Inc.20021
−1K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc.20021
0 (this device)K032261Trellis Reserve Infusion SystemBacchus Vascular, Inc.2003—
+1K050147Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc.2005—
+2K071762Omniwave Endovascular SystemOmnisonics Medical Technologies2007—
+2K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc.2007Class I
+2K130904Trellis-8 Peripheral Infusion SystemCovidien2013Class I
+3K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199310
199510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200721
200820
201311
FIG. 1 — Lineage of K032261, 1990–2013Source: 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.

2 devices in this family have a Class I recall. 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? (1)

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
*K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc.20021

Also cleared against K023514: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K050147Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc.20055

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
  • K130904Trellis-8 Peripheral Infusion SystemCovidien · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • 4 of the 10 ancestors have a recall of any class.
  • Of its descendants, K050147 (Bacchus Vascular, Inc., 2005) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K023514.

How does its category compare?

All QEY devices

QEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

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

Indications for use as stated in the FDA summary.

Also cleared against K023514

1 other device cites the same predicate.

  • K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003

More from Bacchus Vascular, Inc.

10 FDA decisions under this applicant name. See the company

  • K082199Spiralfuse Peripheral Infusion SystemBacchus Vascular, Inc. · 2008
  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 20071 Class I recall
  • K050147Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc. · 2005
  • K033997Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007 110Bacchus Vascular, Inc. · 2004
  • K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 20021 recall

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/K032261 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032261: Trellis Reserve 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/K032261

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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