510(k) · Cleared
ClearedGlucodr Supersensor System
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 Oct 7, 2005 as substantially equivalent to K032552 (Roche Diagnostics Corp., 2003) after a 171-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Oct 7, 2005
- Review
- 171 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032552 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK032552 Accu-Chek Advantage SystemRoche Diagnostics Corp. · 2003
- This deviceK050985 Glucodr Supersensor SystemAll Medicus Co., Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032552 | Accu-Chek Advantage System | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K050985 | Glucodr Supersensor System | All Medicus Co., Ltd. | 2005 | — |
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 |
|---|---|---|---|
| * | K032552 | Accu-Chek Advantage SystemSummary page 1…Product Cod LR 4. Predicate We claim substantial equivalence to the Roche Diagnostics Device Corporation, Accu-Chek Advantage System. (K032552) 5. Device The GlucoDrTM SuperSensor system consists of the GlucoDrim Description SuperSensor Test Meter, G… | 2003 |
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.
- 4 other devices also cite its predicate K032552.
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.
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 SuperSensor 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 from the fingertip.
The GlucoDr TmSuperSensor system may be used by healthcare professionals or for self testing by diabetic lay users in the home.
The GlucoDr TM SuperSensor system is not intended for the diagnosis of or screening for diabetes mellitus.
The GlucoDr TM SuperSensor system is not intended for use on neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050985: Glucodr Supersensor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050985
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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