510(k) · Cleared
ClearedJMS Sysloc Mini Avf and Apheresis Needle Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jms North America Corp. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on May 22, 2007 as substantially equivalent to K051814 (Jms North America Corp., 2005) after a 126-day review. Its family tree reaches back 2 generations to 2003. 6 later devices descend from it.
- Decided
- May 22, 2007
- Review
- 126 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030479 (2003). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK030479 JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle SetJms North America Corp. · 2003
- 1 generation backK051814 JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp. · 2005
- This deviceK070234 JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 2007
- Descendant · cites it directly · 2 of its ownK110157 Sysloc Mini V3JMS 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 ownK142564 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI…JMS North America Corporation · 2014
- 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 · 3 generations on · 0 of its ownK253469 Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm…Mozarc Medical Us, LLC · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110157Sysloc Mini V3JMS North America Corporation · 2011 · cites it directly2descendants
- K082882A.V. Fistula Blunt Needle SetJms North America Corp. · 2009 · cites it directly2descendants
- K142564JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)JMS North America Corporation · 2014 · 2 generations on1descendant
- K093637JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…Jms North America Corp. · 2010 · 2 generations on1descendant
- K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™…Mozarc Medical Us, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030479 | JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set | Jms North America Corp. | 2003 | — |
| −1 | K051814 | JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle Set | Jms North America Corp. | 2005 | — |
| 0 (this device) | K070234 | JMS Sysloc Mini Avf and Apheresis Needle Sets | Jms North America Corp. | 2007 | — |
| +1 | K110157 | Sysloc Mini V3 | JMS North America Corporation | 2011 | — |
| +1 | K082882 | A.V. Fistula Blunt Needle Set | Jms North America Corp. | 2009 | — |
| +2 | K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle… | JMS North America Corporation | 2014 | — |
| +2 | K093637 | JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300… | Jms North America Corp. | 2010 | — |
| +3 | 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 |
|---|---|---|
| 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 MPB? 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 MPB device
- #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 2 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 |
|---|---|---|---|
| * | K051814 | JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetSummary page 1…evice Name The predicate device used in this submission is JMS SysLoc® MINI A.V. Fistula Needle Set & JMS SysLoc® MINI Apheresis Needle Set (K051814, 8/4/2005). 5. Device Intended use SysLoc® MINI V2 is intended for temporary cannulation (non-implanta… | 2005 |
What descends from it? (6)
2 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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K110157 (JMS North America Corporation, 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MPB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPB
205in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPB
4so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · MPB
187in 2025
MAUDE reports naming product code MPB, 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 | 136 | 1 | 41 |
| 2008 | 0 | — | 0 | 147 |
| 2009 | 1 | — | 0 | 166 |
| 2010 | 1 | — | 0 | 60 |
| 2011 | 2 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 78 |
| 2013 | 1 | — | 0 | 124 |
| 2014 | 0 | — | 0 | 82 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 70 |
| 2017 | 2 | — | 2 | 86 |
| 2018 | 0 | — | 0 | 120 |
| 2019 | 0 | — | 0 | 119 |
| 2020 | 3 | 205 | 0 | 179 |
| 2021 | 0 | — | 0 | 192 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 203 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 0 | — | 4 (3) | — |
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/K070234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070234: JMS Sysloc Mini Avf and Apheresis Needle Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070234
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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