510(k) · Cleared
ClearedPhoenix Eletrolyte Calibration Set for the Roche Cobas Ise Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Feb 1, 2002 as substantially equivalent to K902675 (Phoenix Diagnostics, Inc., 1990) after an 18-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Feb 1, 2002
- Review
- 18 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902675 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902675 Multi Analyte Mixture, CalibratorsPhoenix Diagnostics, Inc. · 1990
- This deviceK020129 Phoenix Eletrolyte Calibration Set for the Roche Cobas Ise ModulePhoenix Diagnostics, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902675 | Multi Analyte Mixture, Calibrators | Phoenix Diagnostics, Inc. | 1990 | — |
| 0 (this device) | K020129 | Phoenix Eletrolyte Calibration Set for the Roche Cobas Ise Module | Phoenix Diagnostics, Inc. | 2002 | — |
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 JIX? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K902675 | Multi Analyte Mixture, CalibratorsSummary page 1…Roche® Cobas™ ISE Module. Roche Diagnostics is the original equipment manufacturer (OEM) of the system. The pHoenix products stated are currently cleared under docket K902675. Information herein will support pHoenix’s position to extend the intended use of these products to the Roche® Cobas™ ISE Module.… | 1990 |
| * | — | Roche Product 44224 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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K902675.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The products encompassed by this request are intended for invitro diagnostic use and are intended for use in calibrating Na*, K, CI' electrodes in Roche Cobas ISE module. Roche is the original equipment manufacturer for the analyzer and predicate reagents. phoenix clectrolyte calibration set is intended for use in p of like named products manufactured by Roche Diagnostics.
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/K020129 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020129: Phoenix Eletrolyte Calibration Set for the Roche Cobas Ise Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020129
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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