510(k) · Cleared
ClearedStat Profile Prime Plus Analyzer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Sep 29, 2023 as substantially equivalent to K110648 (Nova Biomedical Corporation, 2011) after a 456-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Sep 29, 2023
- Review
- 456 days
- Class
- Class II
- Product code
- CHL
- 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 deviceK221900 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2023
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) | K221900 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2023 | — |
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 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 14.1 · 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? (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 5…§ 862.9(c)(9) Predicate Device: The predicate device for this submission is the Nova Biomedical Stat Profile pHOx Ultra Analyzer which received clearance through 510(k) K110648. Purpose for Submission: The purpose of this submission is to expand the indication for use to include capillary whole blood spe… | 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 17 years and passes through 2 companies; a new generation was cleared every 12.1 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 CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Potassium, Chloride, Ionized Calcium, Ionized Magnesium, Glucose, and Lactate in heparinized capillary whole blood. pH, pCO2, pO2 measurements are used in the diagnosis…
Read the full statement (259 words)
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Potassium, Chloride, Ionized Calcium, Ionized Magnesium, Glucose, and Lactate in heparinized capillary whole blood.
pH, pCO2, pO2 measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.
Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.
Glucose (Glu) measurement 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 (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
Sodium (Na) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, or diseases involving electrolyte imbalance.
Potassium (K) measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Chloride (Cl) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221900: Stat Profile Prime 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/K221900
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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