510(k) · Cleared
ClearedE-Z Chek Chlorine Residual Test Strips (K100-0101B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reprocessing Products Corporation (Rpc) · MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Cleared on Oct 18, 2022 as substantially equivalent to K901734 (Serim Research Corp., 1990) after an 89-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Oct 18, 2022
- Review
- 89 days
- Class
- Class II
- Product code
- MSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901734 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK901734 Serim Residual Chlorine Test KitSerim Research Corp. · 1990
- This deviceK222167 E-Z Chek Chlorine Residual Test Strips (K100-0101B)Reprocessing Products Corporation (Rpc) · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901734 | Serim Residual Chlorine Test Kit | Serim Research Corp. | 1990 | — |
| 0 (this device) | K222167 | E-Z Chek Chlorine Residual Test Strips (K100-0101B) | Reprocessing Products Corporation (Rpc) | 2022 | — |
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 |
|---|---|---|---|
| * | K901734 | Serim Residual Chlorine Test KitSummary page 4…Class: II Regulation Number: 876.5665 Predicate Device/Substantial Serim Residual Chlorine Test Kit, Equivalence: 510(k) K901734. Reprocessing Products Corporation (RPC) E-Z Chek® Residual Chl… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 other device also cites its predicate K901734.
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. 2022, 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?
E-Z Chek@ Residual Chlorine Test Strips (K100-0101B) provide accurate and convenient means of measuring the concentration of free chlorine remaining in water when rinsing out equipment following disinfection. A rapid screening qualitative method will detect levels above 0.5ppm (mg/L) while the 30 second semi-quantitative method allows interpolation of concentration between Oppm and 5ppm. The qualitative method can be used to determine that chlorine has…
Read the full statement (101 words)
E-Z Chek@ Residual Chlorine Test Strips (K100-0101B) provide accurate and convenient means of measuring the concentration of free chlorine remaining in water when rinsing out equipment following disinfection. A rapid screening qualitative method will detect levels above 0.5ppm (mg/L) while the 30 second semi-quantitative method allows interpolation of concentration between Oppm and 5ppm. The qualitative method can be used to determine that chlorine has been adequately rinsed from the equipment. The semi-quantitative method may be useful when corrective measures are undertaken on equipment retaining higher levels of chlorine for extended periods and for testing any containers disinfected with free chlorine (bleach).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222167: E-Z Chek Chlorine Residual Test Strips (K100-0101B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222167
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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