510(k) · Cleared
ClearedVelano ExT Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Velano Vascular · FPA Set, Administration, Intravascular
Cleared on Feb 23, 2021 as substantially equivalent to K182897 (Velano Vascular, 2019) after a 365-day review. Its family tree reaches back 9 generations to 1995. 2 later devices descend from it.
- Decided
- Feb 23, 2021
- Review
- 365 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K942988 (1995). 19 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 5 generations between
- 3 generations backK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- 2 generations backK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
- 1 generation backK182897 Velano Vascular Q2 Extension SetVelano Vascular · 2019
- This deviceK200439 Velano ExT Extension SetVelano Vascular · 2021
- Descendant · cites it directly · 0 of its ownK251257 nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with…Np Medical · 2025
- Descendant · cites it directly · 0 of its ownK221518 NP Medical nCompass Extension Set with Stabilizing BaseNp Medical · 2022
Show all 9 generations
- Root · 9 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 8 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 7 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 6 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 5 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 4 generations backK132413 MZ1000Care Fusion · 2013
- 3 generations backK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- 2 generations backK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
- 1 generation backK182897 Velano Vascular Q2 Extension SetVelano Vascular · 2019
- This deviceK200439 Velano ExT Extension SetVelano Vascular · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −8 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −7 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −6 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −5 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −4 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| −3 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| −2 | K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | 2017 | — |
| −1 | K182897 | Velano Vascular Q2 Extension Set | Velano Vascular | 2019 | — |
| 0 (this device) | K200439 | Velano ExT Extension Set | Velano Vascular | 2021 | — |
| +1 | K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle… | Np Medical | 2025 | — |
| +1 | K221518 | NP Medical nCompass Extension Set with Stabilizing Base | Np Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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.
Planning a device in FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K182897 | Velano Vascular Q2 Extension SetSummary page 4…t to the following devices: • Velano Vascular Q2® Low Power Injector Extension Set (K182897) Device Description: The Velano ExT™ Extension Set is a sterile, single use, non-… | 2019 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 10 of the 19 ancestors have a recall of any class.
- Of its descendants, K251257 (Np Medical, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Velano ExT™ Extension Set with needle-free connector is for single use only. Each port of the Velano ExT™ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The pressure rated port of the Velano ExT™ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200439: Velano ExT Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200439
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