NDY · Class II · 21 CFR 862.1225

FDA Product Code NDY: Test, Cystatin C

Leading manufacturers include SENTINEL CH. SpA.

22
Total
22
Cleared
126d
Avg days
2001
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 259d recently vs 120d historically

FDA 510(k) Cleared Test, Cystatin C Devices (Product Code NDY)

22 devices
1–22 of 22
Cleared May 16, 2025
Cystatin C
K242585
SENTINEL CH. SpA
Chemistry · 259d

About Product Code NDY - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code NDY since 2001, with 22 receiving FDA clearance (average review time: 126 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under NDY have taken an average of 259 days to reach a decision - up from 120 days historically. Manufacturers should account for longer review timelines in current project planning.

NDY devices are reviewed by the Chemistry panel. Browse all Chemistry devices →