510(k) · Cleared
ClearedE-Z Check Ozone Test Strips
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 Feb 25, 2014 as substantially equivalent to DEN120001 (Phadia US, Inc., 2012) after a 211-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Feb 25, 2014
- Review
- 211 days
- Class
- Class II
- Product code
- MSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN120001 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backDEN120001 Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50…Phadia US, Inc. · 2012
- This deviceK132344 E-Z Check Ozone Test StripsReprocessing Products Corporation (Rpc) · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN120001 | Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator… | Phadia US, Inc. | 2012 | — |
| 0 (this device) | K132344 | E-Z Check Ozone Test Strips | Reprocessing Products Corporation (Rpc) | 2014 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K100118 | Ultra Low Total Chlorine Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | DEN120001 | Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve… Our reading of the summary gave K100106, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120001, Immunocap Tryptase, Calibrators, Curve Control, Conjugate… (Phadia US, Inc.), granted Feb 15, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2012 |
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 DEN120001.
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. 2014, 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 Products Corporation (RPC) E-Z Chek® Ozone Test Strips (K100-0111) are designed to indicate the presence of ozone in water used in hemodialysis. The test strips will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132344: E-Z Check Ozone Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132344
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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