510(k) · Cleared
ClearedUltra Low Total Chlorine, E-Z Chek Sensitive Total Chlorine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reprocessing Products Corp · MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Cleared on May 8, 2009 after an 87-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- May 8, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- MSY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK090338 Ultra Low Total Chlorine, E-Z Chek Sensitive Total ChlorineReprocessing Products Corp · 2009
- Descendant · cites it directly · 1 of its ownK193169 Nelson Sentinel Series Basic Chlorine SentinelNelson Environmental Technologies, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK243898 Chlorine Sentinel IINelson Environmental Technologies, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090338 | Ultra Low Total Chlorine, E-Z Chek Sensitive Total Chlorine | Reprocessing Products Corp | 2009 | — |
| +1 | K193169 | Nelson Sentinel Series Basic Chlorine Sentinel | Nelson Environmental Technologies, Inc. | 2020 | — |
| +2 | K243898 | Chlorine Sentinel II | Nelson Environmental Technologies, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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
- #3 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 |
|---|---|---|---|
| * | — | Serim Ultra 0.1 Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193169 | Nelson Sentinel Series Basic Chlorine Sentinel | 2020 | 1 |
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?
- Of its descendants, K193169 (Nelson Environmental Technologies, Inc., 2020) has gone furthest, with 1 descendant 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. 2009, 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 Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090338: Ultra Low Total Chlorine, E-Z Chek Sensitive Total Chlorine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090338
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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