510(k) · Cleared
ClearedYsi Model 2300 Stat Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ysis, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Oct 2, 1991 after a 37-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 2, 1991
- Review
- 37 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK913806 Ysi Model 2300 Stat PlusYsis, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK980908 Lactate Pro SystemKdk Corp. · 1998
- Descendant · 2 generations on · 1 of its ownK100602 Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test…Nova Biomedical Corp. · 2011
- Descendant · cites it directly · 0 of its ownK210933 YSI 2900C Biochemistry AnalyzerYsi, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK112955 Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012
Most influential descendants
Showing 4 of 4 · See all- K980908Lactate Pro SystemKdk Corp. · 1998 · cites it directly2descendants
- K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011 · 2 generations on1descendant
- K210933YSI 2900C Biochemistry AnalyzerYsi, Inc. · 2024 · cites it directly0descendants
- K112955Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913806 | Ysi Model 2300 Stat Plus | Ysis, Inc. | 1991 | — |
| +1 | K980908 | Lactate Pro System | Kdk Corp. | 1998 | — |
| +2 | K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips | Nova Biomedical Corp. | 2011 | — |
| +1 | K210933 | YSI 2900C Biochemistry Analyzer | Ysi, Inc. | 2024 | — |
| +3 | K112955 | Nova Statstrip Lactate Hospital Meter System | Nova Biomedical Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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, K980908 (Kdk Corp., 1998) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K913806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913806: Ysi Model 2300 Stat Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913806
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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