510(k) · Cleared
ClearedSysloc Mini V3
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 Feb 11, 2011 as substantially equivalent to K070234 (Jms North America Corp., 2007) after a 23-day review. Its family tree reaches back 3 generations to 2003. 2 later devices descend from it.
- Decided
- Feb 11, 2011
- Review
- 23 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K030479 (2003). 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 deviceK110157 Sysloc Mini V3JMS North America Corporation · 2011
- Descendant · cites it directly · 1 of its ownK142564 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI…JMS North America Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK253469 Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm…Mozarc Medical Us, LLC · 2026
Most influential descendants
Showing 2 of 2 · See all- K142564JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)JMS North America Corporation · 2014 · cites it directly1descendant
- K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™…Mozarc Medical Us, LLC · 2026 · 2 generations on0descendants
View 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) | K110157 | Sysloc Mini V3 | JMS North America Corporation | 2011 | — |
| +1 | K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle… | JMS North America Corporation | 2014 | — |
| +2 | K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM)… | Mozarc Medical Us, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K070234 | JMS Sysloc Mini Avf and Apheresis Needle SetsSummary page 1…e Name The predicate device used in this submission is JMS SysLoc@ MINI A.V. Fistula Needle Set &JMS SysLoc@® MINI Apheresis Needle Set (V2) [K070234, dated May 22, 2007]. JMS North America Corporation… | 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 |
|---|---|---|---|
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | 2014 | 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 8 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K142564 (JMS North America Corporation, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K070234.
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 (noni-imnplantable, 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/K110157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110157: Sysloc Mini V3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110157
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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