510(k) · Cleared
ClearedSpectranetics 0.035 Support Catheter, Model 518-028
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics Corp. · DQY Catheter, Percutaneous
Cleared on Sep 23, 2002 as substantially equivalent to K991059 (Spectranetics Corp., 1999) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 1994. 1 of the 111 devices in its family, counting itself, has a Class I recall. 108 later devices descend from it.
- Decided
- Sep 23, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935425 (1994). 108 later devices descend from it, 5 citing it directly. 1 of the 111 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 1 generation backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- This deviceK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- Descendant · cites it directly · 106 of its ownK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- Descendant · 2 generations on · 80 of its ownK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 66 of its ownK072750 Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and…Spectranetics Corp. · 2007
- Descendant · 3 generations on · 44 of its ownK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
- Descendant · cites it directly · 35 of its ownK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141547 Wingman Extendable Tip Support Catheter5 generations on · 2014
Most influential descendants
Showing 5 of 108 · See all- K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…Spectranetics Corp. · 2004 · cites it directly106descendants
- K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005 · 2 generations on80descendants
- K072750Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066Spectranetics Corp. · 2007 · cites it directly66descendants
- K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc. · 2007 · 3 generations on44descendants
- K082337Minnie Support CatheterVascular Solutions, Inc. · 2009 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −1 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| 0 (this device) | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| +1 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| +2 | K052258 | Vascular Solutions Skyway Support Catheter | Vascular Solutions, Inc. | 2005 | — |
| +1 | K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 | Spectranetics Corp. | 2007 | — |
| +3 | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| +1 | K082337 | Minnie Support Catheter | Vascular Solutions, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 11 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 1 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support…Summary page 1…n design, composition, function, and intended use to the Spectranetics Support Catheter, 510(k) K991059, November 6, 1999, and the Medtronic Buchbinder Transfer Catheter, 5 1O(k) K935425.… | 1999 |
| * | K935425 | Metronic Buchbinder Envoy Percutaneous CathetersSummary page 1…eter, 510(k) K991059, November 6, 1999, and the Medtronic Buchbinder Transfer Catheter, 5 1O(k) K935425. THE SPECTRANETICS CORPORATION… | 1994 |
What descends from it? (108)
See all 1085 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036… | 2004 | 106 |
| K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 | 2007 | 66 |
| K082337 | Minnie Support Catheter | 2009 | 35 |
| K082561 | Spectranetics Quick-Cross Extreme Support Catheters | 2008 | 18 |
| K031417 | Ilt Safe Cross 0.035 Support Catheter, Model C135SN1 | 2003 | 0 |
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.
- K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033678 (Spectranetics Corp., 2004) has gone furthest, with 106 descendants of its own.
- 6 other devices also cite its predicate K991059.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Spectranetics Support Catheters are designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022138: Spectranetics 0.035 Support Catheter, Model 518-028.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022138
Report an extraction error
Are you the manufacturer?
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