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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 / January 2026 / K251757

510(k) cleared

Puracyn® Plus Antimicrobial Irrigation Solution

Innovacyn, Inc. · Jan 5, 2026 · K251757

FDA cleared the Puracyn® Plus Antimicrobial Irrigation Solution from Innovacyn, Inc. on Jan 5, 2026 under K251757, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jun 9, 2025. The decision came 210 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 Innovacyn, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251757?

K251757 is the FDA 510(k) for Puracyn® Plus Antimicrobial Irrigation Solution, submitted by Innovacyn, Inc.. FDA's decision date was Jan 5, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the Puracyn® Plus Antimicrobial Irrigation Solution?

Innovacyn, Inc., based in Rialto, CA, is the applicant of record for K251757.

How long did the K251757 review take?

FDA received the submission on Jun 9, 2025 and issued its decision on Jan 5, 2026, 210 days later.

← All decisions in January 2026