510(k) · Cleared
ClearedA.V. Fistula Blunt Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jms North America Corp. · FIE Needle, Fistula
Cleared on Jan 21, 2009 as substantially equivalent to K990803 (Medisystems Corp., 2000) and 2 other predicates after a 113-day review. Its family tree reaches back 3 generations to 2003. 2 later devices descend from it.
- Decided
- Jan 21, 2009
- Review
- 113 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K030479 (2003). 7 ancestors in all, the oldest K823068 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK030479 JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle SetJms North America Corp. · 2003
- 2 generations backK051814 JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp. · 2005
- 1 generation backK070234 JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 2007
- This deviceK082882 A.V. Fistula Blunt Needle SetJms North America Corp. · 2009
- Descendant · cites it directly · 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 ownK151017 JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 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 |
|---|---|---|---|---|---|
| −3 | K030479 | JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set | Jms North America Corp. | 2003 | — |
| −2 | K051814 | JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle Set | Jms North America Corp. | 2005 | — |
| −1 | K070234 | JMS Sysloc Mini Avf and Apheresis Needle Sets | Jms North America Corp. | 2007 | — |
| 0 (this device) | K082882 | A.V. Fistula Blunt Needle Set | Jms North America Corp. | 2009 | — |
| +1 | K093637 | JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300… | Jms North America Corp. | 2010 | — |
| +2 | K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K990803 | Medisystems Buttonhole Needle SetsSummary page 1…V Fistula Blunt Needle Set 4. Predicate Device Information: The predicate device used in this submission is 1) Medisysterns Buttonhole Needle Sets (K990803), 2) JMVS AV Fistula Needle Set WinglEater (KOI 0406) 3) JMVS Sysloc Mini AVF and Apheresis Needle Set (K070234)… | 2000 |
| * | K010406 | JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18GSummary page 2…e Sets (K990803) interms of indications of use and performance characteristics Interms of material, the predicate device is JMS AV Fistula Needle Set WingEater (K010406) and JMS Sysloc Mini AVF and Apheresis Needle Set (K070234) 8. Discussion of Non-Clinical Tests Performed for Determination… | 2001 |
| * | K070234 | JMS Sysloc Mini Avf and Apheresis Needle SetsSummary page 1…1) Medisysterns Buttonhole Needle Sets (K990803), 2) JMVS AV Fistula Needle Set WinglEater (KOI 0406) 3) JMVS Sysloc Mini AVF and Apheresis Needle Set (K070234) ~ 2882. 5 Device Description' J… | 2007 |
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 |
|---|---|---|---|
| K093637 | JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300… | 2010 | 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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K093637 (Jms North America Corp., 2010) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K990803.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The JMS Blunt AV Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment The device is intended for single use only The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082882: A.V. Fistula Blunt Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082882
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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