510(k) · Cleared
ClearedSurshield Winged Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · FPA Set, Administration, Intravascular
Cleared on Mar 15, 2001 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Mar 15, 2001
- Review
- 62 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK010103 Surshield Winged Infusion SetTerumo Medical Corp. · 2001
- Descendant · cites it directly · 7 of its ownK031266 Surshield Safety Winged Infusion SetTerumo Corp. · 2003
- Descendant · 2 generations on · 6 of its ownK052887 Surflo Winged Infusion Set with Needle Protection (Surshield), Model…Terumo Europe N.V. · 2005
- Descendant · 3 generations on · 4 of its ownK070547 Surflo Winged Infusion Set with Filter and Needle Protection…Terumo Europe N.V. · 2007
- Descendant · cites it directly · 4 of its ownK013164 Surshield Safety Winged Blood Collection SetTerumo Medical Corp. · 2001
- Descendant · 2 generations on · 3 of its ownK072894 Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V. · 2007
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K031266Surshield Safety Winged Infusion SetTerumo Corp. · 2003 · cites it directly7descendants
- K052887Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VSTerumo Europe N.V. · 2005 · 2 generations on6descendants
- K070547Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)Terumo Europe N.V. · 2007 · 3 generations on4descendants
- K013164Surshield Safety Winged Blood Collection SetTerumo Medical Corp. · 2001 · cites it directly4descendants
- K072894Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V. · 2007 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010103 | Surshield Winged Infusion Set | Terumo Medical Corp. | 2001 | — |
| +1 | K031266 | Surshield Safety Winged Infusion Set | Terumo Corp. | 2003 | — |
| +2 | K052887 | Surflo Winged Infusion Set with Needle Protection (Surshield), Model… | Terumo Europe N.V. | 2005 | — |
| +3 | K070547 | Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) | Terumo Europe N.V. | 2007 | — |
| +1 | K013164 | Surshield Safety Winged Blood Collection Set | Terumo Medical Corp. | 2001 | — |
| +2 | K072894 | Surflo Winged Infusion Set with Needle Protection (Surshield) | Terumo Europe N.V. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 132 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?
- Of its descendants, K031266 (Terumo Corp., 2003) has gone furthest, with 7 descendants of its own.
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) | — |
https://510kreport.com/device/K010103 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010103: Surshield Winged Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010103
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026