510(k) · Cleared
ClearedSurflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VS
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 Dec 8, 2005 as substantially equivalent to K031266 (Terumo Corp., 2003) after a 56-day review. Its family tree reaches back 2 generations to 2001. 6 later devices descend from it.
- Decided
- Dec 8, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010103 (2001). 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK010103 Surshield Winged Infusion SetTerumo Medical Corp. · 2001
- 1 generation backK031266 Surshield Safety Winged Infusion SetTerumo Corp. · 2003
- This deviceK052887 Surflo Winged Infusion Set with Needle Protection (Surshield), Model…Terumo Europe N.V. · 2005
- Descendant · cites it directly · 4 of its ownK070547 Surflo Winged Infusion Set with Filter and Needle Protection…Terumo Europe N.V. · 2007
- Descendant · cites it directly · 3 of its ownK072894 Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V. · 2007
- Descendant · cites it directly · 2 of its ownK100946 Intravscular Administration SetTerumo Europe N.V. · 2010
- Descendant · 2 generations on · 0 of its ownK140175 Intravascular Administration SetDelta Med Spa · 2014
- Descendant · 2 generations on · 0 of its ownK133894 Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)Terumo Europe N.V. · 2014 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K070547Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)Terumo Europe N.V. · 2007 · cites it directly4descendants
- K072894Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V. · 2007 · cites it directly3descendants
- K100946Intravscular Administration SetTerumo Europe N.V. · 2010 · cites it directly2descendants
- K140175Intravascular Administration SetDelta Med Spa · 2014 · 2 generations on0descendants
- K133894Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)Terumo Europe N.V. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010103 | Surshield Winged Infusion Set | Terumo Medical Corp. | 2001 | — |
| −1 | K031266 | Surshield Safety Winged Infusion Set | Terumo Corp. | 2003 | — |
| 0 (this device) | K052887 | Surflo Winged Infusion Set with Needle Protection (Surshield), Model… | Terumo Europe N.V. | 2005 | — |
| +1 | K070547 | Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) | Terumo Europe N.V. | 2007 | — |
| +1 | K072894 | Surflo Winged Infusion Set with Needle Protection (Surshield) | Terumo Europe N.V. | 2007 | — |
| +1 | K100946 | Intravscular Administration Set | Terumo Europe N.V. | 2010 | — |
| +2 | K140175 | Intravascular Administration Set | Delta Med Spa | 2014 | — |
| +2 | K133894 | Surflo Winged Infusion Set with Filter & Needle Protection (Surshield) | Terumo Europe N.V. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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.
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 |
|---|---|---|---|
| * | K031266 | Surshield Safety Winged Infusion SetSummary page 2…ials and performance to the cleared "Surshield Safety Winged Infusion Set", manufactured by Terumo Medical Products in Hangzhou, China, which is the subject of K031266. 6. Additional Safety Information The sterility of the Surflo Winged Infusion Set with Needle Protection (Surshield) is… | 2003 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070547 | Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) | 2007 | 4 |
| K072894 | Surflo Winged Infusion Set with Needle Protection (Surshield) | 2007 | 3 |
| K100946 | Intravscular Administration Set | 2010 | 2 |
| K133867 | Surflo Winged Infusion Set with Needle Protection (Surshield) | 2014 | 0 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K070547 (Terumo Europe N.V., 2007) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K031266.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/K052887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052887: Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052887
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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