510(k) · Cleared
ClearedPiccolo Potassium Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abaxis, Inc. · MZV Test, System, Potassium, Enzymatic Method
Cleared on Oct 20, 2021 as substantially equivalent to K992140 (Abaxis, Inc., 1999) after a 567-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Oct 20, 2021
- Review
- 567 days
- Class
- Class II
- Product code
- MZV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K830805 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830805 | Knai Sodium Potassium Analyzer | Radiometer America, Inc. | 1983 | — |
| −1 | K992140 | Piccolo Metlyte 7 Reagent Disc | Abaxis, Inc. | 1999 | 2 |
| 0 (this device) | K200865 | Piccolo Potassium Test System | Abaxis, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
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 MZV? 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 |
|---|---|---|---|
| * | K992140 | Piccolo Metlyte 7 Reagent DiscSummary page 4…lass: Class II Product Code: MZV III. PREDICATE DEVICE Primary Predicate: Piccolo® Potassium Test System (included on Piccolo MetLyte 7 Reagent Panel) (K992140) The Siemens Dimension Vista® Integrated System (including the Potassium ISE Test) (K051087) was used as the comparative method.… | 1999 |
| † | K051087 | Dimension Vista Integrated System | 2005 |
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?
- The line of descent spans 38 years and passes through 2 companies; a new generation was cleared every 22.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All MZV devicesMZV Test, System, Potassium, Enzymatic Method: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MZV
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MZV
Too few MZV 510(k)s in any year since 2007 to give a median.
Recalls per year · MZV
No recall names MZV since 2007.
Adverse event reports per year · MZV
1in 2015
MAUDE reports naming product code MZV, 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 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 57 |
| 2012 | 0 | — | 0 | 32 |
| 2013 | 0 | — | 0 | 63 |
| 2014 | 0 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 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?
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum.…
Read the full statement (102 words)
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200865 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200865: Piccolo Potassium Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200865
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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