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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 / July 2026 / K253703

510(k) cleared

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection

Deka R&D Corp · Jul 24, 2026 · K253703

FDA cleared the RemunityPRO+ Pump for Remodulin® (treprostinil) Injection from Deka R&D Corp on Jul 24, 2026 under K253703, a traditional 510(k). The device falls under product code FRN, Pump, Infusion, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Nov 24, 2025. The decision came 242 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 Deka R&D Corp in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253703?

K253703 is the FDA 510(k) for RemunityPRO+ Pump for Remodulin® (treprostinil) Injection, submitted by Deka R&D Corp. FDA's decision date was Jul 24, 2026, under product code FRN (Pump, Infusion).

Who makes the RemunityPRO+ Pump for Remodulin® (treprostinil) Injection?

Deka R&D Corp, based in Manchester, NH, is the applicant of record for K253703.

How long did the K253703 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Jul 24, 2026, 242 days later.

← All decisions in July 2026