510(k) · Cleared
ClearedSterichek Bicarb PH Reagent Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Environmental Test Systems, Inc. · MNV Strip, Dialysate Ph Indicator
Cleared on Dec 23, 2003 after a 246-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 23, 2003
- Review
- 246 days
- Class
- Class II
- Product code
- MNV
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MNV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | SerimTM Bicarb pH II Test Strips Named without a submission number |
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.
How does its category compare?
All MNV devicesMNV Strip, Dialysate Ph Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNV
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · MNV
Too few MNV 510(k)s in any year since 2007 to give a median.
Recalls per year · MNV
No recall names MNV since 2007.
Adverse event reports per year · MNV
No MAUDE report names MNV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of checking the
pH of bicarbonate solution used to prepare dialysate and concentrated bicarbonate
solutions used in the preparation of dialysate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031267: Sterichek Bicarb PH Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031267
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026