FDA Product Code MSY: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Leading manufacturers include Nelson Environmental Technologies, Inc., Serim Research Corp. and Reprocessing Products Corporation (Rpc).
13
Total
13
Cleared
155d
Avg days
1997
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
113d
recently vs 158d historically
FDA 510(k) Cleared Strip, Test, Reagent, Residuals For Dialysate, Disinfectant Devices (Product Code MSY)
13 devices
Cleared
Apr 11, 2025
Chlorine Sentinel II
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology
113d
Cleared
Oct 18, 2022
E-Z Chek Chlorine Residual Test Strips (K100-0101B)
Reprocessing Products Corporation (Rpc)
Gastroenterology & Urology
89d
Cleared
Oct 29, 2020
Nelson Sentinel Series Basic Chlorine Sentinel
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology
349d
Cleared
May 06, 2008
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
Serim Research Corp.
Gastroenterology & Urology
54d
About Product Code MSY - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code MSY since 1997, with 13 receiving FDA clearance (average review time: 155 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - MSY Product Code
Recent submissions under MSY have taken an average of 113 days to reach a decision - down from 158 days historically, suggesting improved FDA processing for this classification.
MSY devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →