510(k) · Cleared
ClearedYsi Model 2300 Stat Glucose and L-Lactate Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yellow Springs Instrument Co., Inc. · CGA Glucose Oxidase, Glucose
Cleared on May 22, 1989 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 22, 1989
- Review
- 66 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK891480 Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerYellow Springs Instrument Co., Inc. · 1989
- Descendant · cites it directly · 0 of its ownK203549 Nova Primary Glucose Analyzer SystemNova Biomedical Corporation · 2022
- Descendant · cites it directly · 0 of its ownK013938 Irma SL Blood Analysis System Lactate CartridgeDiametrics Medical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK011586 Irma SL Blood Analysis System GL CartridgeDiametrics Medical, Inc. · 2001
Most influential descendants
Showing 3 of 3 · See all- K203549Nova Primary Glucose Analyzer SystemNova Biomedical Corporation · 2022 · cites it directly0descendants
- K013938Irma SL Blood Analysis System Lactate CartridgeDiametrics Medical, Inc. · 2002 · cites it directly0descendants
- K011586Irma SL Blood Analysis System GL CartridgeDiametrics Medical, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891480 | Ysi Model 2300 Stat Glucose and L-Lactate Analyzer | Yellow Springs Instrument Co., Inc. | 1989 | — |
| +1 | K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | 2022 | — |
| +1 | K013938 | Irma SL Blood Analysis System Lactate Cartridge | Diametrics Medical, Inc. | 2002 | — |
| +1 | K011586 | Irma SL Blood Analysis System GL Cartridge | Diametrics Medical, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2022 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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, K203549 (Nova Biomedical Corporation, 2022) has gone furthest, with 0 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/K891480 · printed Nov 4, 2026
Cite this page
510(k) Report. “K891480: Ysi Model 2300 Stat Glucose and L-Lactate Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891480
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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