510(k) · Cleared

Cleared

Surshield Safety Winged Infusion Set

K031266510(k) TraditionalCleared May 30, 200339-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Terumo Corp. · FPA Set, Administration, Intravascular

Cleared on May 30, 2003 as substantially equivalent to K010103 (Terumo Medical Corp., 2001) after a 39-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.

Decided: May 30, 2003
Review: 39 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010103 (2001). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK010103 Surshield Winged Infusion SetTerumo Medical Corp. · 2001
This deviceK031266 Surshield Safety Winged Infusion SetTerumo Corp. · 2003
Descendant · cites it directly · 6 of its ownK052887 Surflo Winged Infusion Set with Needle Protection (Surshield), Model…Terumo Europe N.V. · 2005
Descendant · 2 generations on · 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 · 2 generations on · 2 of its ownK100946 Intravscular Administration SetTerumo Europe N.V. · 2010
Descendant · 3 generations on · 0 of its ownK140175 Intravascular Administration SetDelta Med Spa · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005high 3 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all

K052887Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VSTerumo Europe N.V. · 2005 · cites it directly6descendants
K070547Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)Terumo Europe N.V. · 2007 · 2 generations on4descendants
K072894Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V. · 2007 · cites it directly3descendants
K100946Intravscular Administration SetTerumo Europe N.V. · 2010 · 2 generations on2descendants
K140175Intravascular Administration SetDelta Med Spa · 2014 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010103	Surshield Winged Infusion Set	Terumo Medical Corp.	2001	—
0 (this device)	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	—
+2	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	—
+2	K100946	Intravscular Administration Set	Terumo Europe N.V.	2010	—
+3	K140175	Intravascular Administration Set	Delta Med Spa	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	2	0
2010	1	0
2014	3	0

FIG. 1 — Lineage of K031266, 2001–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K010103	Surshield Winged Infusion Set	Terumo Medical Corp.	2001	—

Also cleared against K010103: 1 other device →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052887	Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VS	Terumo Europe N.V.	2005	6
K072894	Surflo Winged Infusion Set with Needle Protection (Surshield)	Terumo Europe N.V.	2007	3

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?

Its one ancestor has no recall.
Of its descendants, K052887 (Terumo Europe N.V., 2005) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K010103.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)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 Surshield Safety Winged Infusion Set is intended for intravenous administration of

fluids andor withdrawal of blood specimens using a syringe, luer adapter, or other

compatible/appropriate devices. The winged infusion set may be used for any patient

population with consideration given to patient size. 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 needlestick.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031266 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031266: Surshield Safety Winged Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031266

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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