510(k) · Cleared
Recalled · 2006Stat Profile Critical Care Xpress Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corp. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Jun 10, 2002 after a 133-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jun 10, 2002
- Review
- 133 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHL? 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 CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2006 | Not classified | Z-0576-06 | Other | Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, 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 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
What is it indicated for?
The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals for the quantitative determination of pH, pC02, p02, S02%, Hct, Hb, Na+, K+, CI-, Ca++, Mg++, Glu, BUN, Lac and Creat in heparinized whole blood, and Na+, K+, CI-, Ca++, Mg++, Glu, BUN, Lac and Creat in serum and plasma. The following list includes the clinical utility information for each of the analytes measured on the CCX Analyzer. Blood…
Read the full statement (447 words)
The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals for the quantitative determination of pH, pC02, p02, S02%, Hct, Hb, Na+, K+, CI-, Ca++, Mg++, Glu, BUN, Lac and Creat in heparinized whole blood, and Na+, K+, CI-, Ca++, Mg++, Glu, BUN, Lac and Creat in serum and plasma.
The following list includes the clinical utility information for each of the analytes measured on the CCX Analyzer.
Blood Gases (PCO,, PO2 and pH): Whole blood measurement of blood gases is used in the diagnosis, and treatment of life-threatening acid-base disturbances in critically ill patients with numerous metabolic and pulmonary diseases.
Oxygen Saturation: Used to assess the oxygenation of hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary function. Also used in the diagnosis and treatment of cyanosis.
Hematocrit: Whole blood measurement of hematocrit is used to estimate that red blood cells are present in sufficient quantity to carry oxygen and carbon dioxide.
Hemoglobin: Oxygen is carried from the lungs throughout the body by hemoglobin present in red blood cells. Measurement of hemoglobin provides the clinician with information regarding the evaluation of chronic and acute anemias and also with information pertaining to the potential oxygen transport capability of the hemoglobin.
Sodium: Measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, or diseases involving electrolyte imbalance.
Potassium: Measurement of potassium is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Chloride: Measurement of chloride is used in the diagnosis and treatment of electrolyte and metabolic disorders such as, cystic fibrosis and diabetic acidosis.
Ionized Calcium: Used in the diagnosis and treatment of hypertension, renal disease, and vitamin D related disorders. Also useful in the diagnosis and treatment of patients with increased total protein and/or albumin levels, as in dehydration.
Ionized Magnesium: Measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
Creatinine: Measurement of creatinine is used in the diagnosis and treatment of certain renal conditions and is used for monitoring adequacy of dialysis, for example, peritoneal dialysis and peritoneal equilibration testing.
Glucose: Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate: Measurement of lactic acid (lactate) in whole blood, serum, and plasma is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
Urea Nitrogen: Measurement of urea nitrogen is used in the diagnosis and treatment of certain renal and metabolic diseases.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K020297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020297: Stat Profile Critical Care Xpress Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020297
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026