510(k) · Cleared
ClearedEasygluco, Model Igm-0002 G2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U. S. Diagnostics, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Jan 12, 2007 as substantially equivalent to K024194 (Lifescan, Inc., 2003) and 2 other predicates after a 233-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jan 12, 2007
- Review
- 233 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942455 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942455 | Lifescan Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1995 | — |
| −1 | K984261 | Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1999 | — |
| 0 (this device) | K061431 | Easygluco, Model Igm-0002 G2 | U. S. Diagnostics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsSummary page 2…he EASYGLUCOTM G2 Blood Glucose Monitoring System is substantially equivalent to the following predicate devices: K024194- LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K0215… | 2003 |
| * | K984261 | Surestep Blood Glucose Monitoring SystemSummary page 2…substantially equivalent to the following predicate devices: K024194- LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential… | 1999 |
| * | K021513 | Accu-Chek Advantage ModuleSummary page 2…devices: K024194- LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential Page 2… | 2002 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 14 other devices also cite its predicate K024194.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 EASYGLUCOTM Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. EASYGLUCOTM System is for testing outside the body (in vitro diagnostic use only). The EASYGLUCO Diabetes Monitoring System is not for use with neonatal blood specimens. Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, calf and thigh.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061431: Easygluco, Model Igm-0002 G2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061431
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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