510(k) · Cleared
ClearedIVD-GE02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sphere Medical, Ltd. · CGA Glucose Oxidase, Glucose
Cleared on Mar 16, 2011 as substantially equivalent to K934907 (Ciba Corning Diagnostics Corp., 1994) after a 247-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 16, 2011
- Review
- 247 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934907 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK934907 860 Measurment SystemCiba Corning Diagnostics Corp. · 1994
- This deviceK101947 IVD-GE02Sphere Medical, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934907 | 860 Measurment System | Ciba Corning Diagnostics Corp. | 1994 | — |
| 0 (this device) | K101947 | IVD-GE02 | Sphere Medical, Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K934907 | 860 Measurment SystemSummary page 2…ME Rapidlab 865 MANUFACTURER Siemens Healthcare ______________________ Diagnostics 510(K) NUMBER K934907 DESCRIPTION OF DEVICE The IVD-GEO2 system is an in-vitro diagnostic device for the determination of specified analytes in bl… | 1994 |
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.
- 3 other devices also cite its predicate K934907.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 JVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurement of PH, PCO 2 , P02, potassium and glucose. pH, PCO2, P02: Measurement of blood gases (PCO 2 , PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Potassium: Measurement of potassium…
Read the full statement (149 words)
The JVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurement of PH, PCO 2 , P02, potassium and glucose.
pH, PCO2, P02: Measurement of blood gases (PCO 2 , PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Potassium: Measurement of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by high or low potassium levels.
Glucose: Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathetic hypoglycaemnia and of pancreatic islet cell carcinoma.
IVD-GE02 calibration solutions are in vitro diagnostic products for the calibration of the IVD-GE02 test system for the measurements of pH, pCO2, p02, potassium and glucose.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101947: IVD-GE02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101947
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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