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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 / November 2025 / K250586

510(k) cleared

Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory

Deroyal Industries, Inc. · Nov 21, 2025 · K250586

FDA cleared the Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory from Deroyal Industries, Inc. on Nov 21, 2025 under K250586, a traditional 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 Feb 27, 2025. The decision came 267 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 Deroyal Industries, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250586?

K250586 is the FDA 510(k) for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory, submitted by Deroyal Industries, Inc.. FDA's decision date was Nov 21, 2025, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory?

Deroyal Industries, Inc., based in Powell, TN, is the applicant of record for K250586.

How long did the K250586 review take?

FDA received the submission on Feb 27, 2025 and issued its decision on Nov 21, 2025, 267 days later.

← All decisions in November 2025