510(k) · Cleared
ClearedSurflo Winged Infusion Set with Needle Protection (Surshield)
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 Feb 5, 2014 as substantially equivalent to K052887 (Terumo Europe N.V., 2005) and 2 other predicates after a 47-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Feb 5, 2014
- Review
- 47 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K970259 (1997). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 4 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 3 generations backK033350 BD Vacutainer Safety-Lok Administration Set with FilterBecton, Dickinson & CO · 2003
- 2 generations backK070547 Surflo Winged Infusion Set with Filter and Needle Protection…Terumo Europe N.V. · 2007
- 1 generation backK100946 Intravscular Administration SetTerumo Europe N.V. · 2010
- This deviceK133867 Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −4 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| −3 | K033350 | BD Vacutainer Safety-Lok Administration Set with Filter | Becton, Dickinson & CO | 2003 | — |
| −2 | K070547 | Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) | Terumo Europe N.V. | 2007 | — |
| −1 | K100946 | Intravscular Administration Set | Terumo Europe N.V. | 2010 | — |
| 0 (this device) | 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 |
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 3…d microbore tubing, to provide supporting information that despite of some changes in material, design, process and labeling to the devices cleared under K052887, K072894 and K 100946, the proposed devices are safe and effective and substantially equivalent to the devices cleared un… | 2005 |
| * | K072894 | Surflo Winged Infusion Set with Needle Protection (Surshield)Summary page 3…re tubing, to provide supporting information that despite of some changes in material, design, process and labeling to the devices cleared under K052887, K072894 and K 100946, the proposed devices are safe and effective and substantially equivalent to the devices cleared under K0528… | 2007 |
| * | K100946 | Intravscular Administration SetSummary page 3…o provide supporting information that despite of some changes in material, design, process and labeling to the devices cleared under K052887, K072894 and K 100946, the proposed devices are safe and effective and substantially equivalent to the devices cleared under K052887, K072894 a… | 2010 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 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. 2014, 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 as stated in the FDA summary.
https://510kreport.com/device/K133867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133867: Surflo Winged Infusion Set with Needle Protection (Surshield).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133867
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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