510(k) · Cleared
ClearedPoly-Chem 90 Ise Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymedco, Inc. · CEM Electrode, Ion Specific, Potassium
Cleared on Nov 4, 2011 as substantially equivalent to K024014 (Randox Laboratories, Ltd., 2003) after a 74-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Nov 4, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024014 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK024014 Randox RX DaytonaRandox Laboratories, Ltd. · 2003 · Recalled
- This deviceK112408 Poly-Chem 90 Ise ModulePolymedco, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024014 | Randox RX Daytona | Randox Laboratories, Ltd. | 2003 | 1 |
| 0 (this device) | K112408 | Poly-Chem 90 Ise Module | Polymedco, Inc. | 2011 | — |
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 CEM? 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 CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 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 |
|---|---|---|---|
| * | K024014 | Randox RX DaytonaSummary page 1…11 Predicate Device: Randox RX Daytona ISE Module Device common name: Ion selective electrode module; test for sodium, potassium, chloride 5 10(k) number: K024014 Product code: IGS, GEM, CGZ Regulation number: 862.1665, 862.1600, 862.1170 Classification: Class 11 Device… | 2003 |
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 a recall.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | 1 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of sodium, potassium, and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by…
Read the full statement (125 words)
The Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of sodium,
potassium, and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer.
Sodium measurements are used in the diagnosis and treatment of aldosteronism
(excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion
of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension,
Addison's disease (caused by destruction of the adrenal glands), dehydration,
inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte
imbalance.
Potassium measurements are used to monitor electrolyte balance in the diagnosis and
treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and
metabolic disorders such as cystic fibrosis and diabetic acidosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112408: Poly-Chem 90 Ise Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112408
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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