510(k) · Cleared
ClearedYSI 2900C Biochemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ysi, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Sep 30, 2024 as substantially equivalent to K913806 (Ysis, Inc., 1991) after a 1,281-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 30, 2024
- Review
- 1,281 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913806 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913806 Ysi Model 2300 Stat PlusYsis, Inc. · 1991
- This deviceK210933 YSI 2900C Biochemistry AnalyzerYsi, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913806 | Ysi Model 2300 Stat Plus | Ysis, Inc. | 1991 | — |
| 0 (this device) | K210933 | YSI 2900C Biochemistry Analyzer | Ysi, Inc. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913806 | Ysi Model 2300 Stat PlusSummary page 4…Predicate Device/Claims of Equivalence against YSI marketed MODEL 23A GLUCOSE ANALYZER; YSI 2300 STAT PLUS (referenced throughout as 2300 STAT PLUS). Reference 510(k): K913806. There have been no prior applications or submissions for the review/approval of the YSI 2900C BIOCHEMISTRY ANALYZER. Descripti… | 1991 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K913806.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The YSI 2900C Biochemistry Analyzer is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of venous whole blood samples, fingerstick capillary whole blood samples, serum and plasma in the laboratory. For in vitro diagnostic use. Glucose measurements from the YSI 2900C Biochemistry Analyzer are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus…
Read the full statement (114 words)
The YSI 2900C Biochemistry Analyzer is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of venous whole blood samples, fingerstick capillary whole blood samples, serum and plasma in the laboratory.
For in vitro diagnostic use.
Glucose measurements from the YSI 2900C Biochemistry Analyzer are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell tumors. The YSI 2900C Biochemistry Analyzer is not intended for use in the screening or quantitative analysis on neonates. The YSI 2900C Biochemistry Analyzer is not intended for point of care (POC) use.
This test is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210933: YSI 2900C Biochemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210933
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026