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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 / May 2026 / K261291

510(k) cleared

Nisus NPWT Canister 500-mL (CPC-500)

Cork Medical · May 21, 2026 · K261291

FDA cleared the Nisus NPWT Canister 500-mL (CPC-500) from Cork Medical on May 21, 2026 under K261291, a special 510(k). The device falls under product code OMP, Negative Pressure Wound Therapy Powered Suction Pump, regulated at 21 CFR 878.4780 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Apr 20, 2026. The decision came 31 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Cork Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261291?

K261291 is the FDA 510(k) for Nisus NPWT Canister 500-mL (CPC-500), submitted by Cork Medical. FDA's decision date was May 21, 2026, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the Nisus NPWT Canister 500-mL (CPC-500)?

Cork Medical, based in Indianapolis, IN, is the applicant of record for K261291.

How long did the K261291 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on May 21, 2026, 31 days later.

← All decisions in May 2026