510(k) · Cleared
ClearedSurflo Winged Infusion Set
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 May 7, 2007 as substantially equivalent to K891063 (Terumo Medical Corp., 1989) after an 89-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- May 7, 2007
- Review
- 89 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891063 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK891063 Surflo (R) Winged Infusion SetTerumo Medical Corp. · 1989
- This deviceK070362 Surflo Winged Infusion SetTerumo Europe N.V. · 2007
- Descendant · cites it directly · 1 of its ownK152323 Disposable Infusion Needle, Safelock Disposable Infusion NeedleJiangyin Caina Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK221078 Intravenous Needles for Single Use,Safety Intravenous Needles for…Sichuan Prius Biotechnology Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See all- K152323Disposable Infusion Needle, Safelock Disposable Infusion NeedleJiangyin Caina Technology Co., Ltd. · 2015 · cites it directly1descendant
- K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single UseSichuan Prius Biotechnology Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891063 | Surflo (R) Winged Infusion Set | Terumo Medical Corp. | 1989 | — |
| 0 (this device) | K070362 | Surflo Winged Infusion Set | Terumo Europe N.V. | 2007 | — |
| +1 | K152323 | Disposable Infusion Needle, Safelock Disposable Infusion Needle | Jiangyin Caina Technology Co., Ltd. | 2015 | — |
| +2 | K221078 | Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K891063 | Surflo (R) Winged Infusion SetSummary page 1…rinciples of operation, materials and performance to the cleared "Surflo Winged Infusion Set", manufactured by Terumo Medical Corporation, which is the subject of K891063. Page 8… | 1989 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152323 | Disposable Infusion Needle, Safelock Disposable Infusion Needle | 2015 | 1 |
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, K152323 (Jiangyin Caina Technology Co., Ltd., 2015) has gone furthest, with 1 descendant 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. 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070362: Surflo 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/K070362
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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