510(k) · Cleared
ClearedStat Profile Ultra F,G,H,I,J, and K Analyzers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corp. · JFP Electrode, Ion Specific, Calcium
Cleared on Mar 11, 1996 after a 60-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Mar 11, 1996
- Review
- 60 days
- Class
- Class II
- Product code
- JFP
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK960120 Stat Profile Ultra F,G,H,I,J, and K AnalyzersNova Biomedical Corp. · 1996
- Descendant · cites it directly · 7 of its ownK990092 Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999 · Recalled
- Descendant · 2 generations on · 2 of its ownK013373 Omni C AnalyzerRoche Diagnostics Corp. · 2001 · Recalled
- Descendant · 2 generations on · 2 of its ownK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
- Descendant · 3 generations on · 1 of its ownK131126 Opti Cca-TS2Opti Medical Systems, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK032311 Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. · 2003 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K990092Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999 · cites it directly7descendants
- K013373Omni C AnalyzerRoche Diagnostics Corp. · 2001 · 2 generations on2descendants
- K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · 2 generations on2descendants
- K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · 3 generations on1descendant
- K032311Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. · 2003 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960120 | Stat Profile Ultra F,G,H,I,J, and K Analyzers | Nova Biomedical Corp. | 1996 | — |
| +1 | K990092 | Avl Omni Modular Analyzer | Avl Scientific Corp. | 1999 | 4 |
| +2 | K013373 | Omni C Analyzer | Roche Diagnostics Corp. | 2001 | 1 |
| +2 | K993837 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1999 | — |
| +3 | K131126 | Opti Cca-TS2 | Opti Medical Systems, Inc. | 2013 | — |
| +2 | K032311 | Roche Diagnostics Omni S Analyzer | Roche Diagnostics Corp. | 2003 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JFP? 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 JFP device
- #1 K230300 i-STAT CG8+ cartridge with the i-STAT 1 Systemscore 6.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K990092 (Avl Scientific Corp., 1999) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JFP devicesJFP Electrode, Ion Specific, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JFP
Too few JFP 510(k)s in any year since 2007 to give a median.
Recalls per year · JFP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFP
40in 2025
MAUDE reports naming product code JFP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 5 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K960120 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960120: Stat Profile Ultra F,G,H,I,J, and K Analyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960120
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026