510(k) · Cleared
ClearedStat Profile Prime ES Comp Plus Analyzer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · JGS Electrode, Ion Specific, Sodium
Cleared on Jul 19, 2019 as substantially equivalent to K110648 (Nova Biomedical Corporation, 2011) after a 58-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Jul 19, 2019
- Review
- 58 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K061830 (2006). No later device cites it as a predicate yet.
- Root · 2 generations backK061830 Stat Profile Critical Care Xpress (CCX), Model 1+Nova Biomedical Corp. · 2006
- 1 generation backK110648 Nova Stat Profile Phox Ultra Analyzer SystemNova Biomedical Corporation · 2011
- This deviceK191365 Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K061830 | Stat Profile Critical Care Xpress (CCX), Model 1+ | Nova Biomedical Corp. | 2006 | — |
| −1 | K110648 | Nova Stat Profile Phox Ultra Analyzer System | Nova Biomedical Corporation | 2011 | — |
| 0 (this device) | K191365 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | 2019 | — |
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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 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 |
|---|---|---|---|
| * | K110648 | Nova Stat Profile Phox Ultra Analyzer SystemSummary page 4…CGZ (75) Analyzer, chemistry (photometric, discrete), for clinical use 862.2160 I JJE Product Codes: JGS, CEM, CGZ Predicate Devices: K110648 - Nova Stat Profile pHOx Ultra Blood Gas Analyzer Device Description: The Stat Profile Prime ES Comp Plus Analyzer is a small,… | 2011 |
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 13 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
- 8 other devices also cite its predicate K110648.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of Sodium, Potassium, and Chloride in heparinized venous whole blood, plasma and serum. Sodium (Na) Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases…
Read the full statement (114 words)
The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of Sodium, Potassium, and Chloride in heparinized venous whole blood, plasma and serum.
Sodium (Na)
Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
Potassium (K)
Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Chloride (Cl)
Chloride measurement is 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/K191365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191365: Stat Profile Prime ES Comp Plus Analyzer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191365
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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