510(k) · Cleared
ClearedNova Stat Profile 5 Analyzer + Quality Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corp. · JGS Electrode, Ion Specific, Sodium
Cleared on Feb 11, 1988 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Feb 11, 1988
- Review
- 79 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK874832 Nova Stat Profile 5 Analyzer + Quality ControlNova Biomedical Corp. · 1988
- Descendant · cites it directly · 5 of its ownK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- Descendant · cites it directly · 4 of its ownK984299 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- 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 · 4 generations on · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly5descendants
- K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly4descendants
- K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · 2 generations on2descendants
- K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · 3 generations on1descendant
- K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K874832 | Nova Stat Profile 5 Analyzer + Quality Control | Nova Biomedical Corp. | 1988 | — |
| +1 | K974784 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| +1 | K984299 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| +2 | K993837 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1999 | — |
| +3 | K131126 | Opti Cca-TS2 | Opti Medical Systems, Inc. | 2013 | — |
| +4 | K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2005 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 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, K974784 (Avl Scientific Corp., 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K874832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K874832: Nova Stat Profile 5 Analyzer + Quality Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874832
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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