510(k) · Cleared
ClearedJMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jms Co., Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jun 20, 2001 after a 128-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jun 20, 2001
- Review
- 128 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK010406 JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18GJms Co., Ltd. · 2001
- Descendant · cites it directly · 2 of its ownK111948 Wingeater V2JMS North America Corporation · 2011
- Descendant · cites it directly · 2 of its ownK082882 A.V. Fistula Blunt Needle SetJms North America Corp. · 2009
- Descendant · 2 generations on · 1 of its ownK093637 JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model…Jms North America Corp. · 2010
- Descendant · 2 generations on · 0 of its ownK251877 JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK151017 JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K111948Wingeater V2JMS North America Corporation · 2011 · cites it directly2descendants
- K082882A.V. Fistula Blunt Needle SetJms North America Corp. · 2009 · cites it directly2descendants
- K093637JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…Jms North America Corp. · 2010 · 2 generations on1descendant
- K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation · 2025 · 2 generations on0descendants
- K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010406 | JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G | Jms Co., Ltd. | 2001 | — |
| +1 | K111948 | Wingeater V2 | JMS North America Corporation | 2011 | — |
| +1 | K082882 | A.V. Fistula Blunt Needle Set | Jms North America Corp. | 2009 | — |
| +2 | K093637 | JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300… | Jms North America Corp. | 2010 | — |
| +2 | K251877 | JMS CAVEO A.V. Fistula Needle Set | JMS North America Corporation | 2025 | — |
| +3 | K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2025 | 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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
4 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, K111948 (JMS North America Corporation, 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
https://510kreport.com/device/K010406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010406: JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010406
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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