510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251281Substantially Equivalent

Nova Max Creat eGFR Monitoring System

Nova Biomedical Corporation, Walham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251281 is the FDA 510(k) clearance record for Nova Max Creat eGFR Monitoring System, a class II device, cleared for Nova Biomedical Corporation on under FDA product code SHB (Creatinine Test System For At Home Prescription Use). FDA's definition for product code SHB reads: "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". FDA records list 129 510(k) clearances for Nova Biomedical Corporation, from to . As of , FDA records show no recalls naming K251281.

Clearance record

Decision date
Received
(272 days to decision)
Product code
SHB Creatinine Test System For At Home Prescription Use
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Nova Biomedical Corporation 200 Prospect St., Walham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SHB

Trailing 12 months
1 clearance under product code SHB in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260