510(k) · Cleared
ClearedJMS Sysloc Mini a.V. Fistula Needle Set and Apheresis 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 Aug 4, 2005 as substantially equivalent to K030479 (Jms North America Corp., 2003) after a 30-day review. Its family tree reaches back 1 generation to 2003. 7 later devices descend from it.
- Decided
- Aug 4, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030479 (2003). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK030479 JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle SetJms North America Corp. · 2003
- This deviceK051814 JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp. · 2005
- Descendant · cites it directly · 6 of its ownK070234 JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 2007
- Descendant · 2 generations on · 2 of its ownK110157 Sysloc Mini V3JMS North America Corporation · 2011
- Descendant · 2 generations on · 2 of its ownK082882 A.V. Fistula Blunt Needle SetJms North America Corp. · 2009
- Descendant · 3 generations on · 1 of its ownK142564 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI…JMS North America Corporation · 2014
- Descendant · 3 generations on · 1 of its ownK093637 JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model…Jms North America Corp. · 2010
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K070234JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 2007 · cites it directly6descendants
- K110157Sysloc Mini V3JMS North America Corporation · 2011 · 2 generations on2descendants
- K082882A.V. Fistula Blunt Needle SetJms North America Corp. · 2009 · 2 generations on2descendants
- K142564JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)JMS North America Corporation · 2014 · 3 generations on1descendant
- K093637JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…Jms North America Corp. · 2010 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030479 | JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set | Jms North America Corp. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K110157 | Sysloc Mini V3 | JMS North America Corporation | 2011 | — |
| +2 | K082882 | A.V. Fistula Blunt Needle Set | Jms North America Corp. | 2009 | — |
| +3 | K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle… | JMS North America Corporation | 2014 | — |
| +3 | K093637 | JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300… | Jms North America Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K030479 | JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle SetSummary page 1…edicate Device Name The predicate device used in this submission is JIMS SysLoc® A.V. Fistula Needle Set & JMS SysLoc® Apheresis Needle Set (K030479, 8/1 8/2003). 4. Device Intended use JIMS SysLoc MIN ITm A.V. Fistula Needle Set & JMVS SysLoc MIN IT… | 2003 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070234 | JMS Sysloc Mini Avf and Apheresis Needle Sets | 2007 | 6 |
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?
- Its one ancestor has no recall.
- Of its descendants, K070234 (Jms North America Corp., 2007) has gone furthest, with 6 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 (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051814: JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis 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/K051814
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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