510(k) · Cleared
ClearedStat Profile M7 Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corp. · CGL Electrode, Ion Based, Enzymatic, Creatinine
Cleared on Jul 16, 1999 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 16, 1999
- Review
- 57 days
- Class
- Class II
- Product code
- CGL
- Recalls
- None
- 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 CGL? 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 CGL device
- #1 K261039 i-STAT Crea cartridge with the i-STAT 1 Systemscore 11.9 · 2 generations · no Class I recall
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CGL devicesCGL Electrode, Ion Based, Enzymatic, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGL
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · CGL
Too few CGL 510(k)s in any year since 2007 to give a median.
Recalls per year · CGL
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGL
8in 2025
MAUDE reports naming product code CGL, 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 | — | 3 | 17 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 1 | 6 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage in the quantitative determination of sodium, potassium, chloride, ionized calcium, creatinine, glucose, lactate, and BUN in serum, plasma and whole blood.; of pH, PCO2, PO2, oxygen saturation, hematocrit and hemoglobin in whole blood.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991727 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991727: Stat Profile M7 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991727
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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