510(k) · Cleared
ClearedSpiralfuse Peripheral Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bacchus Vascular, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Oct 17, 2008 as substantially equivalent to K071664 (Bacchus Vascular, Inc., 2007) after a 74-day review. Its family tree reaches back 9 generations to 1990. 1 of the 14 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 17, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K904788 (1990). 13 ancestors in all. No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 5 generations between
- 3 generations backK032261 Trellis Reserve Infusion SystemBacchus Vascular, Inc. · 2003
- 2 generations backK050147 Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc. · 2005
- 1 generation backK071664 Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · Recalled (Class I)
- This deviceK082199 Spiralfuse Peripheral Infusion SystemBacchus Vascular, Inc. · 2008
Show all 9 generations
- Root · 9 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 8 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 7 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 6 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 5 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 4 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 3 generations backK032261 Trellis Reserve Infusion SystemBacchus Vascular, Inc. · 2003
- 2 generations backK050147 Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc. · 2005
- 1 generation backK071664 Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · Recalled (Class I)
- This deviceK082199 Spiralfuse Peripheral Infusion SystemBacchus Vascular, Inc. · 2008
Class I recalls in this family
- K071664 Trellis-6 Peripheral Infusion Systemdirect predicate · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −8 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −7 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −6 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −5 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −4 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −3 | K032261 | Trellis Reserve Infusion System | Bacchus Vascular, Inc. | 2003 | — |
| −2 | K050147 | Trellis-8 Peripheral Infusion System | Bacchus Vascular, Inc. | 2005 | — |
| −1 | K071664 | Trellis-6 Peripheral Infusion System | Bacchus Vascular, Inc. | 2007 | Class I |
| 0 (this device) | K082199 | Spiralfuse Peripheral Infusion System | Bacchus Vascular, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 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.
1 device in this family has 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 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071664 | Trellis-6 Peripheral Infusion SystemSummary page 5…tive infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature. PredicateDevice: Trellis-6 Infusion System K071664 Bacchus Vascular, Inc Device Description: The SpiralFuse Peripheral Infusion System is a simpler version of the Tr… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · QEY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEY
62in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEY
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEY
5in 2025
MAUDE reports naming product code QEY, 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 | 28 | 0 | 0 |
| 2008 | 4 | 54 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | 144 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 5 | 91 | 0 | 0 |
| 2020 | 3 | 158 | 0 | 0 |
| 2021 | 3 | 62 | 0 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
SpiralFuse Peripheral 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.
https://510kreport.com/device/K082199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082199: Spiralfuse Peripheral 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/K082199
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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