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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 / K253326

510(k) cleared

Oxiplex

Fziomed, Inc. · May 1, 2026 · K253326

FDA cleared the Oxiplex from Fziomed, Inc. on May 1, 2026 under K253326, a traditional 510(k). The device falls under product code QVL, Absorbable Gel For Intraoperative Use In Spine Surgery, regulated at 21 CFR 888.3047 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2025. The decision came 213 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 Fziomed, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253326?

K253326 is the FDA 510(k) for Oxiplex, submitted by Fziomed, Inc.. FDA's decision date was May 1, 2026, under product code QVL (Absorbable Gel For Intraoperative Use In Spine Surgery).

Who makes the Oxiplex?

Fziomed, Inc., based in San Luis Obispo, CA, is the applicant of record for K253326.

How long did the K253326 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on May 1, 2026, 213 days later.

← All decisions in May 2026