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THE TAPE

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 / K251511

510(k) cleared

PhenoMATRIX

Copan Wasp Srl · Jan 22, 2026 · K251511

FDA cleared the PhenoMATRIX from Copan Wasp Srl on Jan 22, 2026 under K251511, a traditional 510(k). The device falls under product code PPU, Microbial Colony Image Assessment System, regulated at 21 CFR 866.2190 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on May 16, 2025. The decision came 251 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 Copan Wasp Srl in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251511?

K251511 is the FDA 510(k) for PhenoMATRIX, submitted by Copan Wasp Srl. FDA's decision date was Jan 22, 2026, under product code PPU (Microbial Colony Image Assessment System).

Who makes the PhenoMATRIX?

Copan Wasp Srl, based in Brescia, is the applicant of record for K251511.

How long did the K251511 review take?

FDA received the submission on May 16, 2025 and issued its decision on Jan 22, 2026, 251 days later.

← All decisions in January 2026