510(k) · Cleared
ClearedGlucodr Plus System, Model Agm-3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
All Medicus Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Feb 27, 2009 as substantially equivalent to K043474 (Roche Diagnostics Corp., 2005) after a 197-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Feb 27, 2009
- Review
- 197 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010362 (2001). 3 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 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −1 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| 0 (this device) | K082328 | Glucodr Plus System, Model Agm-3000 | All Medicus Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 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 |
|---|---|---|---|
| * | K043474 | Accu-Chek Aviva SystemSummary page 1…Product Code : JJX) 4. Predicate We claim substantial equivalence to the Roche Diagnostics Device Corporation, Accu-Chek Aviva System. (K043474) 5. DeviceTMpuT The GlucoDrT M Plus system consists of GlucoDrTM Plus Test Meter, GlucoDrTM Descripti… | 2005 |
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 8 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 9 other devices also cite its predicate K043474.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The GlucoDrTM Plus system is intended for in vitro diagnostic use (i.e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood. Testing sites include traditional fingertip site along with palm, arm and thigh. The GlucoDrTM Plus system may be used by healthcare professionals or for self testing by diabetic lay users with diabetes mellitus at home as aid in monitoring the effectiveness of diabetes…
Read the full statement (126 words)
The GlucoDrTM Plus system is intended for in vitro diagnostic use (i.e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood. Testing sites include traditional fingertip site along with palm, arm and thigh.
The GlucoDrTM Plus system may be used by healthcare professionals or for self testing by diabetic lay users with diabetes mellitus at home as aid in monitoring the effectiveness of diabetes control program.
The GlucoDrTM Plus system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The GlucoDrTM Plus control solution is for use with the The GlucoDrTM Plus meters and strips as a quality control check to verify the accuracy of blood glucose test results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082328: Glucodr Plus System, Model Agm-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082328
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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