510(k) · Cleared
ClearedIntravscular Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Europe N.V. · FPA Set, Administration, Intravascular
Cleared on Aug 2, 2010 as substantially equivalent to K052887 (Terumo Europe N.V., 2005) and 2 other predicates after a 118-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 2, 2010
- Review
- 118 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K970259 (1997). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 3 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 2 generations backK033350 BD Vacutainer Safety-Lok Administration Set with FilterBecton, Dickinson & CO · 2003
- 1 generation backK070547 Surflo Winged Infusion Set with Filter and Needle Protection…Terumo Europe N.V. · 2007
- This deviceK100946 Intravscular Administration SetTerumo Europe N.V. · 2010
- Descendant · cites it directly · 0 of its ownK140175 Intravascular Administration SetDelta Med Spa · 2014
- Descendant · cites it directly · 0 of its ownK133867 Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V. · 2014
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 |
|---|---|---|---|---|---|
| −4 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −3 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| −2 | K033350 | BD Vacutainer Safety-Lok Administration Set with Filter | Becton, Dickinson & CO | 2003 | — |
| −1 | K070547 | Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) | Terumo Europe N.V. | 2007 | — |
| 0 (this device) | K100946 | Intravscular Administration Set | Terumo Europe N.V. | 2010 | — |
| +1 | K140175 | Intravascular Administration Set | Delta Med Spa | 2014 | — |
| +1 | K133867 | Surflo Winged Infusion Set with Needle Protection (Surshield) | Terumo Europe N.V. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K052887 | Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VSSummary page 1…ification: Class 1] Reasop for Submission This 510k-is being submitted to extend Terumo Europe's cleared Surflo Winged Infusion Set with Needie Protection (Surshield) (K052887 and K072894) product line to inchide 23G and 25G needle sizes with microbore tubing taking into consideration the potential issue… | 2005 |
| * | K072894 | Surflo Winged Infusion Set with Needle Protection (Surshield)Summary page 1…lass 1] Reasop for Submission This 510k-is being submitted to extend Terumo Europe's cleared Surflo Winged Infusion Set with Needie Protection (Surshield) (K052887 and K072894) product line to inchide 23G and 25G needle sizes with microbore tubing taking into consideration the potential issues of safety… | 2007 |
| * | K070547 | Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)Summary page 2…fusion Set with Needle Protection (Surshield) (K072894), manufactured hy Terumo Europe N.V. 3. Surflo'Winged Infusion Set with Filter and Needle Protection (Surshield) (K070547), manufactured by Terumo Europe N.V. Any differences between the devices do not raise any significant issues of safety and effec… | 2007 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K140175 (Delta Med Spa, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K052887.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient’s vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.
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/K100946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100946: Intravscular Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100946
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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