510(k) · Cleared
ClearedDuo-Care Blood Glucose and Blood Pressure Monitor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genexel-Sein, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Feb 20, 2009 as substantially equivalent to K052108 (Sein Electronics Co., Ltd., 2005) after a 331-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Feb 20, 2009
- Review
- 331 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021239 (2002). 8 ancestors in all, the oldest K002134 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK021239 Eikon Automatic Digital Blood Pressure Monitor, Model HD-400MEikon Healthcare Device Corp. · 2002
- 3 generations backK040159 Apm Blood Pressure Monitor, Model BP108AAsia Pacific Microsystems, Inc. · 2004
- 2 generations backK042795 Clever Chek TD-3213Taidoc Technology Corporation · 2005
- 1 generation backK052108 Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd. · 2005
- This deviceK080853 Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021239 | Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M | Eikon Healthcare Device Corp. | 2002 | — |
| −3 | K040159 | Apm Blood Pressure Monitor, Model BP108A | Asia Pacific Microsystems, Inc. | 2004 | — |
| −2 | K042795 | Clever Chek TD-3213 | Taidoc Technology Corporation | 2005 | — |
| −1 | K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 | Sein Electronics Co., Ltd. | 2005 | — |
| 0 (this device) | K080853 | Duo-Care Blood Glucose and Blood Pressure Monitor System | Genexel-Sein, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Summary page 1…ose oxidase, glucose Single (specified) analyte controls System, measurement, blood-pressure, non-invasive 15- Substantial Equivalency is claimed against 510K #K052108 16- Description of the Device: DUO-CARE Genexel-Sein Blood Glucose & Pressure Monitor system combines the function of a blood gl… | 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 7 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K052108.
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 DUO-CARE blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor…
Read the full statement (138 words)
The DUO-CARE blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.
Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement.
The system includes optional accessory software that is installed on the users' computers for data management purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080853 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080853: Duo-Care Blood Glucose and Blood Pressure Monitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080853
Report an extraction error
Are you the manufacturer?
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