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 · GGZ Oxyhemoglobin
Cleared on Aug 23, 2018 as substantially equivalent to K110648 (Nova Biomedical Corporation, 2011) after a 212-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Aug 23, 2018
- Review
- 212 days
- Class
- Class II
- Product code
- GGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K061830 (2006). 1 later device descends from it, 1 citing it directly.
- 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 deviceK180186 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018
- Descendant · cites it directly · 0 of its ownK200204 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2020
Most influential descendants
Showing 1 of 1 · See all- K200204Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2020 · cites it directly0descendants
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) | K180186 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018 | — |
| +1 | K200204 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 GGZ? 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 GGZ device
- #1 K200204 Stat Profile Prime Plus Analyzer Systemscore -0.3 · 3 generations · no Class I recall
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…emoglobin assay Class II GHS 21 CFR § 864.5620 Automated hemoglobin system Class II GKR Product Code: GGZ Predicate Device: K110648 - Stat Profile pHOx Ultra Analyzer System Device Description: The Stat Profile Prime Plus Analyzer System is designed to be a lo… | 2011 |
| † | K131703 | Nova Stat Profile Prime CCS Analyzer System | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200204 | Stat Profile Prime Plus Analyzer System | 2020 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K200204 (Nova Biomedical Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K110648.
How does its category compare?
All GGZ devicesGGZ Oxyhemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GGZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GGZ
Too few GGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GGZ
No recall names GGZ since 2007.
Adverse event reports per year · GGZ
No MAUDE report names GGZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 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 Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin, in heparinized arterial and venous whole blood. Hct Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as…
Read the full statement (233 words)
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin, in heparinized arterial and venous whole blood.
Hct Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.
SO2 Oxygen Saturation (SO2) measurements are used to assess the oxygenation of the hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary function. Measurements are also used to diagnose and treat cyanosis.
tHb Total Hemoglobin (tHb) measurements are used in the evaluation of chronic and acute anemia as well as the oxygen transport capability of the hemoglobin.
O2Hb Oxyhemoglobin (O2Hb) measurements are used to assess pulmonary function in combination with Deoxyhemoglobin and are also used in the diagnosis and treatment of cyanosis.
COHb Carboxyhemoglobin (COHb) measurements are used to determine if and to what level carbon monoxide has been inhaled by the patient. High levels of carbon monoxide can lead to tissue anoxia and death.
MetHb Methemoglobin (MetHb) measurements are used to determine congenital methemoglobinemia or determine the ingestion of nitrates, chlorates, or any other drug or chemical that can cause methemoglobin formation. High levels of methemoglobin can lead to cyanosis and death.
HHb Deoxyhemoglobin (HHb) measurements are used to assess pulmonary function in combination with Oxyhemoglobin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180186: 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/K180186
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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