510(k) · Cleared
ClearedRitus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mozarc Medical Us, LLC · FIE Needle, Fistula
Cleared on Aug 6, 2026 as substantially equivalent to K142564 (JMS North America Corporation, 2014) after a 300-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Aug 6, 2026
- Review
- 300 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K030479 (2003). No later device cites it as a predicate yet.
- Root · 5 generations backK030479 JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle SetJms North America Corp. · 2003
- 4 generations backK051814 JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp. · 2005
- 3 generations backK070234 JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 2007
- 2 generations backK110157 Sysloc Mini V3JMS North America Corporation · 2011
- 1 generation backK142564 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI…JMS North America Corporation · 2014
- This deviceK253469 Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm…Mozarc Medical Us, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K030479 | JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set | Jms North America Corp. | 2003 | — |
| −4 | K051814 | JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle Set | Jms North America Corp. | 2005 | — |
| −3 | K070234 | JMS Sysloc Mini Avf and Apheresis Needle Sets | Jms North America Corp. | 2007 | — |
| −2 | 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 | — |
| 0 (this device) | K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM)… | Mozarc Medical Us, LLC | 2026 | — |
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 K251877 JMS CAVEO A.V. Fistula Needle Setscore 10.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)Summary page 5…FIE FDA Review Panel Gastroenterology and Urology 3. Predicate Device Predicate Device: JMS SysLoc MINI A.V. Fistula Needle Set (V4) (K142564) Reference Device: SUPERCATH V (K052267) 4. Device Description The Ritus™ Safety Fistula Cannulas with Anti-Reflux Valve are co… | 2014 |
| † | K052267 | Supercath V | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Ritus™ Safety Fistula Cannula is intended for use gaining percutaneous vascular access via arteriovenous (AV) fistula for blood removal and blood reinfusion during dialysis, in patients 18 years or older, with kidney failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253469: Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253469
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026