510(k) · Cleared
ClearedABL90 FLEX PLUS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medicals Aps · JGS Electrode, Ion Specific, Sodium
Cleared on May 1, 2026 as substantially equivalent to K200403 (Nova Biomedical Corporation, 2020) after a 267-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- May 1, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K061830 (2006). No later device cites it as a predicate yet.
- Root · 4 generations backK061830 Stat Profile Critical Care Xpress (CCX), Model 1+Nova Biomedical Corp. · 2006
- 3 generations backK110648 Nova Stat Profile Phox Ultra Analyzer SystemNova Biomedical Corporation · 2011
- 2 generations backK180428 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018
- 1 generation backK200403 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2020 · Recalled
- This deviceK252475 ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K061830 | Stat Profile Critical Care Xpress (CCX), Model 1+ | Nova Biomedical Corp. | 2006 | — |
| −3 | K110648 | Nova Stat Profile Phox Ultra Analyzer System | Nova Biomedical Corporation | 2011 | — |
| −2 | K180428 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018 | — |
| −1 | K200403 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020 | 2 |
| 0 (this device) | K252475 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026 | — |
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 K213486 GLP systems Trackscore 7.5 · 6 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 |
|---|---|---|---|
| * | K200403 | Stat Profile Prime Plus Analyzer SystemSummary page 5…Class II Predicate Device Device Trade Name: Stat Profile Prime Plus Analyzer System Common Name: Blood Analyzer 510(k) : K200403 Regulations: 21 CFR 862.1665, Sodium test system 21 CFR 862.1170, Chloride test system… | 2020 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures electrolytes: - cCl- in heparinized arterial, venous and capillary whole blood, and - cCa2+ and cNa+ in heparinized capillary whole blood. The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These…
Read the full statement (152 words)
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures electrolytes:
- cCl- in heparinized arterial, venous and capillary whole blood, and
- cCa2+ and cNa+ in heparinized capillary whole blood.
The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting.
These tests are only performed under a physician's order.
Calcium (cCa2+): Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Sodium (cNa+): Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Chloride (cCl–): 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/K252475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252475: ABL90 FLEX PLUS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252475
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026