510(k) · Cleared
ClearedNelson Sentinel Series Basic Chlorine Sentinel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nelson Environmental Technologies, Inc. · MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Cleared on Oct 29, 2020 as substantially equivalent to K090338 (Reprocessing Products Corp, 2009) after a 349-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Oct 29, 2020
- Review
- 349 days
- Class
- Class II
- Product code
- MSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090338 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK090338 Ultra Low Total Chlorine, E-Z Chek Sensitive Total ChlorineReprocessing Products Corp · 2009
- This deviceK193169 Nelson Sentinel Series Basic Chlorine SentinelNelson Environmental Technologies, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK243898 Chlorine Sentinel IINelson Environmental Technologies, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243898Chlorine Sentinel IINelson Environmental Technologies, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090338 | Ultra Low Total Chlorine, E-Z Chek Sensitive Total Chlorine | Reprocessing Products Corp | 2009 | — |
| 0 (this device) | K193169 | Nelson Sentinel Series Basic Chlorine Sentinel | Nelson Environmental Technologies, Inc. | 2020 | — |
| +1 | K243898 | Chlorine Sentinel II | Nelson Environmental Technologies, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSY device
- #1 K243898 Chlorine Sentinel IIscore 9.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090338 | Ultra Low Total Chlorine, E-Z Chek Sensitive Total ChlorineSummary page 4…Total Chlorine Test Strips 510(k) Submitter / Holder Reprocessing Products Corporation (RPC) 510(k) Number K090338 21 CFR§ 876.5665 Water purification system for Regulation Number… | 2009 |
| † | K162471 | Hach CM130 Chlorine Monitoring System | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243898 | Chlorine Sentinel II | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K243898 (Nelson Environmental Technologies, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MSY devicesMSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MSY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSY
Too few MSY 510(k)s in any year since 2007 to give a median.
Recalls per year · MSY
No recall names MSY since 2007.
Adverse event reports per year · MSY
1in 2011
MAUDE reports naming product code MSY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 35 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total Chlorine. (i.e. total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193169 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193169: Nelson Sentinel Series Basic Chlorine Sentinel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193169
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026