510(k) · Cleared
ClearedWingeater V2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
JMS North America Corporation · FIE Needle, Fistula
Cleared on Oct 24, 2011 as substantially equivalent to K010406 (Jms Co., Ltd., 2001) after a 108-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Oct 24, 2011
- Review
- 108 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010406 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010406 JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18GJms Co., Ltd. · 2001
- This deviceK111948 Wingeater V2JMS North America Corporation · 2011
- Descendant · cites it directly · 0 of its ownK251877 JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation · 2025
- Descendant · cites it directly · 0 of its ownK131950 Angel Tip Safety Intravascular Needle SetSummit International Medical Technologies, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010406 | JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G | Jms Co., Ltd. | 2001 | — |
| 0 (this device) | K111948 | Wingeater V2 | JMS North America Corporation | 2011 | — |
| +1 | K251877 | JMS CAVEO A.V. Fistula Needle Set | JMS North America Corporation | 2025 | — |
| +1 | K131950 | Angel Tip Safety Intravascular Needle Set | Summit International Medical Technologies, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2025 | 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 FIE? 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 FIE device
- #1 K253469 Ritus™ Safety Fistula Cannula with Anti-Reflux…score 13.0 · 5 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 |
|---|---|---|---|
| * | K010406 | JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18GSummary page 1…"WingEater®V2 (21 CFR 876-5540) as Class 11. Predicate Device Name Predicate device used in this submission is JMS A.V. Fistula Needle Set "WingEater®V1 (510(k) number- K010406, cleared on June 20, 2001). ~K ' Dev… | 2001 |
| † | K000845 | Modification to JMS a.V. Fistula Needle Set | 2000 |
What descends from it? (2)
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?
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FIE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIE
91in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIE
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIE
33in 2025
MAUDE reports naming product code FIE, 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 | 3 | 90 | 0 | 13 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 27 |
| 2010 | 3 | 29 | 0 | 17 |
| 2011 | 3 | 91 | 0 | 2 |
| 2012 | 1 | — | 3 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 1 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 21 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 58 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and .WingEater guard) aids in prevention of needlestick injuries when removing and discarding needle after dialysis session.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111948 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111948: Wingeater V2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111948
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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