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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K253469

510(k) cleared

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)

Mozarc Medical Us, LLC · Aug 6, 2026 · K253469

FDA cleared the 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) from Mozarc Medical Us, LLC on Aug 6, 2026 under K253469, a traditional 510(k). The device falls under product code FIE, Needle, Fistula, regulated at 21 CFR 876.5540 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Oct 10, 2025. The decision came 300 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Mozarc Medical Us, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253469?

K253469 is the FDA 510(k) for 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), submitted by Mozarc Medical Us, LLC. FDA's decision date was Aug 6, 2026, under product code FIE (Needle, Fistula).

Who makes the 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)?

Mozarc Medical Us, LLC, based in Mansfield, MA, is the applicant of record for K253469.

How long did the K253469 review take?

FDA received the submission on Oct 10, 2025 and issued its decision on Aug 6, 2026, 300 days later.

← All decisions in August 2026