Chlorine Sentinel II

Q: What is the product code of K243898?

The FDA product code is MSY – Strip, Test, Reagent, Residuals For Dialysate, Disinfectant, a Class II (moderate risk) device regulated under 21 CFR 876.5665.

FDA 510(k) K243898 · Nelson Environmental Technologies, Inc.

Substantially Equivalent

510(k) numberK243898

Submission

Device name: Chlorine Sentinel II
Applicant: Nelson Environmental Technologies, Inc.
Mcallen, TX, US
Received: December 19, 2024
Decision date: April 11, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MSY – Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5665
Specialty: Gastroenterology, Urology
Life-sustaining: Yes

Other 510(k)s with product code MSY

510(k)	Device	Applicant	Decision
K222167	E-Z Chek Chlorine Residual Test Strips (K100-0101B)MSY · Traditional	Reprocessing Products Corporation (Rpc)	10/18/2022SE
K193169	Nelson Sentinel Series Basic Chlorine SentinelMSY · Traditional	Nelson Environmental Technologies, Inc.	10/29/2020SE
K132344	E-Z Check Ozone Test StripsMSY · Traditional	Reprocessing Products Corporation (Rpc)	02/25/2014SE
K090338	Ultra Low Total Chlorine, E-Z Chek Sensitive Total ChlorineMSY · Traditional	Reprocessing Products Corp	05/08/2009SE
K080712	Serim Hisense Ultra 0.1, Part Number 5167MSY · Traditional	Serim Research Corp.	05/06/2008SE
K002011	Glutartest 1 Reagent StripMSY · Traditional	Integrated Biomedical Technology, Inc.	01/22/2001SE
K001194	Sterichek Total Chlorine Reagent StripsMSY · Traditional	Environmental Test Systems, Inc.	07/11/2000SE
K994226	Sterichek Total Chlorine Reagent StripsMSY · Traditional	Environmental Test Systems, Inc.	03/22/2000SE
K983997	Sterichek Total Chlorine Test KitMSY · Traditional	Environmental Test Systems, Inc.	04/02/1999SE
K974064	Micro X Residual Test StripsMSY · Traditional	Reprocessing Products Corp	12/07/1998SE

More from Reprocessing Products Corp

510(k)	Device	Decision
K193169	Nelson Sentinel Series Basic Chlorine SentinelMSY · Traditional	10/29/2020SE
K993877	Nelson Water Systems for HemodialysisFIP · Traditional	05/25/2000SE

Questions and answers

When was Chlorine Sentinel II cleared by the FDA?

Chlorine Sentinel II (K243898) received a 510(k) decision of Substantially Equivalent on April 11, 2025, 113 days after the submission was received.

What is the product code of K243898?

The FDA product code is MSY – Strip, Test, Reagent, Residuals For Dialysate, Disinfectant, a Class II (moderate risk) device regulated under 21 CFR 876.5665.