Cleared Traditional

Nova Max Creat eGFR Monitoring System

K251281 · Nova Biomedical Corporation · Chemistry
Jan 2026
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K251281 is an FDA 510(k) clearance for the Nova Max Creat eGFR Monitoring System, a Creatinine Test System For At Home Prescription Use (Class II — Special Controls, product code SHB), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on January 21, 2026, 272 days after receiving the submission on April 24, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K251281 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2025
Decision Date January 21, 2026
Days to Decision 272 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code SHB — Creatinine Test System For At Home Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225
Definition For The Quantitative Measurement Of Creatinine In Home Use Settings By Patients As An Aid To Monitor Kidney Function. This Device Is For Prescription Use Only.