510(k) · Cleared
ClearedJMS a. V. Fistula Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jms Co., Ltd. · FIE Needle, Fistula
Cleared on Aug 30, 1999 after a 195-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Aug 30, 1999
- Review
- 195 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK990470 JMS a. V. Fistula Needle SetJms Co., Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK171505 Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and…Dimesol, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK151017 JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015
- Descendant · cites it directly · 0 of its ownK112734 Aplan a.V. Fistula Needle SetAplan Well Enterprise Co., Ltd. · 2012
Most influential descendants
Showing 3 of 3 · See all- K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV…Dimesol, Inc. · 2018 · cites it directly0descendants
- K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015 · cites it directly0descendants
- K112734Aplan a.V. Fistula Needle SetAplan Well Enterprise Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990470 | JMS a. V. Fistula Needle Set | Jms Co., Ltd. | 1999 | — |
| +1 | K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol… | Dimesol, Inc. | 2018 | — |
| +1 | K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015 | — |
| +1 | K112734 | Aplan a.V. Fistula Needle Set | Aplan Well Enterprise Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 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, K171505 (Dimesol, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 fcr vascular access for extracorporeal blood treatment. This device is intended to single use only and is for temporary catheterization less than 30 days. Regarding to pre-attached Anti-stick device, use for prevention of needlestick injury at the time of needle withdrawal after usage.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990470 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990470: JMS a. V. Fistula Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990470
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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