510(k) · Cleared
ClearednSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Np Medical · FPA Set, Administration, Intravascular
Cleared on Dec 4, 2025 as substantially equivalent to K200439 (Velano Vascular, 2021) after a 225-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Dec 4, 2025
- Review
- 225 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K942988 (1995). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 6 generations between
- 3 generations backK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
- 2 generations backK182897 Velano Vascular Q2 Extension SetVelano Vascular · 2019
- 1 generation backK200439 Velano ExT Extension SetVelano Vascular · 2021
- This deviceK251257 nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with…Np Medical · 2025
Show all 10 generations
- Root · 10 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 9 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 8 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 7 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 6 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 5 generations backK132413 MZ1000Care Fusion · 2013
- 4 generations backK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- 3 generations backK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
- 2 generations backK182897 Velano Vascular Q2 Extension SetVelano Vascular · 2019
- 1 generation backK200439 Velano ExT Extension SetVelano Vascular · 2021
- This deviceK251257 nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with…Np Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −9 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −8 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −7 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −6 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −5 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| −4 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| −3 | K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | 2017 | — |
| −2 | K182897 | Velano Vascular Q2 Extension Set | Velano Vascular | 2019 | — |
| −1 | K200439 | Velano ExT Extension Set | Velano Vascular | 2021 | — |
| 0 (this device) | K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle… | Np Medical | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K200439 | Velano ExT Extension SetSummary page 5…880.5440 Product Code(s) FPA | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200439 Velano ExT Extension Set FPA Device Description Summary 21 CFR 807.92(a)(4) Product Name: nSet+ Stabilization Set Part Number:… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 10 of the 20 ancestors have a recall of any class.
- 1 other device also cites its predicate K200439.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 nSet+ Stabilization Set is for single use only. The nSet+ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSet+ 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. The nSet+ Stabilization Set with nSyte needle free connector is for single use only. The nSet+ Extension Set may be used for direct injection…
Read the full statement (164 words)
The nSet+ Stabilization Set is for single use only. The nSet+ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSet+ 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.
The nSet+ Stabilization Set with nSyte needle free connector is for single use only. The nSet+ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSet+ Stabilization Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.
The nSyte needle free connector is for single use only. The nSyte needle free connector may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSyte needle free connector 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251257: nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251257
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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