WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / K251281

510(k) cleared

Nova Max Creat eGFR Monitoring System

Nova Biomedical Corporation · Jan 21, 2026 · K251281

FDA cleared the Nova Max Creat eGFR Monitoring System from Nova Biomedical Corporation on Jan 21, 2026 under K251281, a traditional 510(k). The device falls under product code SHB, Creatinine Test System For At Home Prescription Use, regulated at 21 CFR 862.1225 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Apr 24, 2025. The decision came 272 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nova Biomedical Corporation has one other decision in the tracker over the last 12 months: K252206 (Nova Allegro UACR Assay, Nova Allegro Analyzer).

Questions & Answers

What did FDA clear under K251281?

K251281 is the FDA 510(k) for Nova Max Creat eGFR Monitoring System, submitted by Nova Biomedical Corporation. FDA's decision date was Jan 21, 2026, under product code SHB (Creatinine Test System For At Home Prescription Use).

Who makes the Nova Max Creat eGFR Monitoring System?

Nova Biomedical Corporation, based in Walham, MA, is the applicant of record for K251281.

How long did the K251281 review take?

FDA received the submission on Apr 24, 2025 and issued its decision on Jan 21, 2026, 272 days later.

← All decisions in January 2026

Sources