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 Nov 6, 2007 as substantially equivalent to K052887 (Terumo Europe N.V., 2005) and 1 other predicate after a 26-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Nov 6, 2007
- Review
- 26 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010103 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010103 Surshield Winged Infusion SetTerumo Medical Corp. · 2001
- 2 generations backK031266 Surshield Safety Winged Infusion SetTerumo Corp. · 2003
- 1 generation backK052887 Surflo Winged Infusion Set with Needle Protection (Surshield), Model…Terumo Europe N.V. · 2005
- This deviceK072894 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 · cites it directly · 0 of its ownK133867 Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V. · 2014
Most influential descendants
Showing 3 of 3 · See all- K100946Intravscular Administration SetTerumo Europe N.V. · 2010 · cites it directly2descendants
- K140175Intravascular Administration SetDelta Med Spa · 2014 · 2 generations on0descendants
- K133867Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010103 | Surshield Winged Infusion Set | Terumo Medical Corp. | 2001 | — |
| −2 | K031266 | Surshield Safety Winged Infusion Set | Terumo Corp. | 2003 | — |
| −1 | K052887 | Surflo Winged Infusion Set with Needle Protection (Surshield), Model… | Terumo Europe N.V. | 2005 | — |
| 0 (this device) | 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 | — |
| +1 | K133867 | Surflo Winged Infusion Set with Needle Protection (Surshield) | Terumo Europe N.V. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (2)
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…ion: Class II 2. Reason for Submission This 510k is being submitted to extend the cleared Surflo Winged Infusion Set with Needle Protection (Surshield) (K052887) product line to include a 25 Gauge needle size taking into consideration the potential issues of safety and effectiveness… | 2005 |
| * | K031266 | Surshield Safety Winged Infusion SetSummary page 2…inged Infusion Set with Needle Protection (Surshield) (K052887), manufactured by Terumo Europe N.V. 2. 25G Surshield Safety Winged Infusion Set (K031266), manufactured by Teruno Medical Products (Hangzhou), China Any differences between the devices do not raise… | 2003 |
What descends from it? (3)
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 6 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K100946 (Terumo Europe N.V., 2010) has gone furthest, with 2 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. 2007, 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/K072894 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072894: 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 4, 2026. https://510kreport.com/device/K072894
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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