510(k) · Cleared
ClearedSurshield Safety Winged Blood Collection 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 Oct 15, 2001 as substantially equivalent to K010103 (Terumo Medical Corp., 2001) and 2 other predicates after a 24-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it.
- Decided
- Oct 15, 2001
- Review
- 24 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970259 (1997). 5 ancestors in all, the oldest K931367 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 1 generation backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- This deviceK013164 Surshield Safety Winged Blood Collection SetTerumo Medical Corp. · 2001
- Descendant · cites it directly · 3 of its ownK031279 Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd. · 2003
- Descendant · 2 generations on · 0 of its ownK192681 Safety scalp vein set, Scalp vein set, Blood collection needle…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK151991 Safelock Disposable Blood Collection Set, Disposable Blood…Jiangyin Caina Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK043328 Microflo-Safe Scalp Vein SetDks Loversan Industria Biomedica Spa · 2005
Most influential descendants
Showing 4 of 4 · See all- K031279Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd. · 2003 · cites it directly3descendants
- K192681Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type)…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2020 · 2 generations on0descendants
- K151991Safelock Disposable Blood Collection Set, Disposable Blood Collection SetJiangyin Caina Technology Co., Ltd. · 2015 · 2 generations on0descendants
- K043328Microflo-Safe Scalp Vein SetDks Loversan Industria Biomedica Spa · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −1 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| 0 (this device) | K013164 | Surshield Safety Winged Blood Collection Set | Terumo Medical Corp. | 2001 | — |
| +1 | K031279 | Surshield Safety Winged Blood Collection Set | Terumo Medical Products Hangzhou Co., Ltd. | 2003 | — |
| +2 | K192681 | Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2020 | — |
| +2 | K151991 | Safelock Disposable Blood Collection Set, Disposable Blood Collection Set | Jiangyin Caina Technology Co., Ltd. | 2015 | — |
| +2 | K043328 | Microflo-Safe Scalp Vein Set | Dks Loversan Industria Biomedica Spa | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K010103 | Surshield Winged Infusion SetSummary page 1…ed devices both manufactured by Terumo Corporation in Tokyo, Japan. The base " predicate device is the SURSHIELD™ SAFETY WINGED INFUSION SET cleared under 510(k) number K010103 and the attached device is the TERUMO® VENOJECT® LUER ADAPTER cleared under 510(k) number K983490. The focus of this submission i… | 2001 |
| * | K983490 | Terumo Venoject,Luer AdapterSummary page 1…s the SURSHIELD™ SAFETY WINGED INFUSION SET cleared under 510(k) number K010103 and the attached device is the TERUMO® VENOJECT® LUER ADAPTER cleared under 510(k) number K983490. The focus of this submission is to address any potential issues of safety and effectiveness of the device being formed after joi… | 1998 |
| * | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood…Summary page 2…leared devices: 1. TERUMO® SURSHIELD SAFETY WINGED INFUSION SET —~K010103 2. TERUMO® VENOJECT® LUER ADAPTER - K983490 3. VACUTAINER® SAFETY-LOK™ BLOOD COLLECTION SET —-K980414 Differences between the devices do not raise any significant issues of safety and effectiveness. F. Principals of Operation/Tec… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031279 | Surshield Safety Winged Blood Collection Set | 2003 | 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K031279 (Terumo Medical Products Hangzhou Co., Ltd., 2003) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K010103.
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 TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients. The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any…
Read the full statement (116 words)
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
Additionally, after withdraw of the needle from the patient’s vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013164: Surshield Safety Winged Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013164
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026