510(k) · Cleared
ClearedNova Stat Profile Phox Ultra 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 Aug 29, 2011 as substantially equivalent to K061830 (Nova Biomedical Corp., 2006) after a 178-day review. Its family tree reaches back 1 generation to 2006. 16 later devices descend from it.
- Decided
- Aug 29, 2011
- Review
- 178 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061830 (2006). 16 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK061830 Stat Profile Critical Care Xpress (CCX), Model 1+Nova Biomedical Corp. · 2006
- This deviceK110648 Nova Stat Profile Phox Ultra Analyzer SystemNova Biomedical Corporation · 2011
- Descendant · cites it directly · 3 of its ownK131703 Nova Stat Profile Prime CCS Analyzer SystemNova Biomedical Corporation · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK180428 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK200403 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK180340 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018
- Descendant · cites it directly · 1 of its ownK180186 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K131703Nova Stat Profile Prime CCS Analyzer SystemNova Biomedical Corporation · 2014 · cites it directly3descendants
- K180428Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018 · cites it directly2descendants
- K200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2020 · 2 generations on1descendant
- K180340Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018 · cites it directly1descendant
- K180186Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061830 | Stat Profile Critical Care Xpress (CCX), Model 1+ | Nova Biomedical Corp. | 2006 | — |
| 0 (this device) | K110648 | Nova Stat Profile Phox Ultra Analyzer System | Nova Biomedical Corporation | 2011 | — |
| +1 | K131703 | Nova Stat Profile Prime CCS Analyzer System | Nova Biomedical Corporation | 2014 | 1 |
| +1 | K180428 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018 | — |
| +2 | K200403 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020 | 2 |
| +1 | K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018 | — |
| +1 | K180186 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K061830 | Stat Profile Critical Care Xpress (CCX), Model 1+Summary page 2…Page 1 of 5 Device Description: As in the Nova Stat Profile Critical Care Xpress (CCX), Model 1+Analyzer System (K061830) predicate device, the Nova Stat Profile pHOx Ultra Analyzer System combines Blood Gas/pH, Chemistry. bilirubin and CO-Oximetry t… | 2006 |
What descends from it? (16)
See all 169 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131703 | Nova Stat Profile Prime CCS Analyzer System | 2014 | 3 |
| K180428 | Stat Profile Prime Plus Analyzer System | 2018 | 2 |
| K180340 | Stat Profile Prime Plus Analyzer System | 2018 | 1 |
| K180186 | Stat Profile Prime Plus Analyzer System | 2018 | 1 |
| K173797 | Stat Profile Prime Plus Analyzer System | 2018 | 1 |
| K221900 | Stat Profile Prime Plus Analyzer System | 2023 | 0 |
| K200349 | Stat Profile Prime Plus Analyzer System | 2020 | 0 |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer System | 2019 | 0 |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer System | 2019 | 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?
- Its one ancestor has no recall.
- Of its descendants, K131703 (Nova Biomedical Corporation, 2014) has gone furthest, with 3 descendants of its own.
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. 2011, 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 Nova Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PC02, P02, S02%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Nat, K'-, Cl-, Ca++, Mg++, Glucose (Glu), Lactate…
Read the full statement (280 words)
The Nova Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PC02, P02, S02%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Nat, K'-, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.
The Nova Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PC02, P02, S02%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K'-, CI-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Utea), and Creatinine (Great) in helparinized whole blood, serum, or plasma.
The intended use of the Nova STP pHOx Ultra Calibrator Cartridge isfor the quantitative determination of pH, PC02, P02, S02%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na'-, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Great) in heparinized whole blood, serum, or plasma.
The intended use of the Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2H-b), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using the Nova Stat Profile pHOx Ultra Analyzer System with CO-Oximeter.
Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Controls and Autocartridge QG are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Stat Profile pHOx Ultra Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110648: Nova Stat Profile Phox Ultra 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/K110648
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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