510(k) · Cleared
ClearedMyglucohealth Glucose Monitoring Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entra Health Systems, Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jan 8, 2009 as substantially equivalent to K072369 (Hmd Biomedical, LLC, 2008) after a 205-day review. Its family tree reaches back 3 generations to 1995. 10 later devices descend from it.
- Decided
- Jan 8, 2009
- Review
- 205 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950727 (1995). 4 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
- 2 generations backK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · Recalled
- 1 generation backK072369 Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008
- This deviceK081703 Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 2009
- Descendant · cites it directly · 8 of its ownK113105 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK152124 Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015
- Descendant · 3 generations on · 6 of its ownK152645 Dictum HealthDictum Health, Inc. · 2016
- Descendant · 4 generations on · 5 of its ownK170798 Dictum HealthDictum Health, Inc. · 2017
- Descendant · 5 generations on · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011 · cites it directly8descendants
- K152124Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015 · 2 generations on7descendants
- K152645Dictum HealthDictum Health, Inc. · 2016 · 3 generations on6descendants
- K170798Dictum HealthDictum Health, Inc. · 2017 · 4 generations on5descendants
- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950727 | One Touch Profile Complete Diabetes Tracking System | Lifescan, Inc. | 1995 | — |
| −2 | K021819 | One Touch Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | 2002 | 1 |
| −1 | K072369 | Evolution Blood Glucose Monitoring System | Hmd Biomedical, LLC | 2008 | — |
| 0 (this device) | K081703 | Myglucohealth Glucose Monitoring Systems | Entra Health Systems, Ltd. | 2009 | — |
| +1 | K113105 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2011 | — |
| +2 | K152124 | Tempus IC2 | Remote Diagnostics Technologies, Ltd. | 2015 | — |
| +3 | K152645 | Dictum Health | Dictum Health, Inc. | 2016 | — |
| +4 | K170798 | Dictum Health | Dictum Health, Inc. | 2017 | — |
| +5 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K072369 | Evolution Blood Glucose Monitoring SystemSummary page 1…art 807.92 DEVICE NAME: Myglucohealth Models MGH-lI and MGH-BT1I PREDICATE DEVICE FIMD Biomedical "Evolution" blood glucose monitor (reference K072369) DESCRIPTION: Reference CLASSIFICATION: 862.1345: Blood glucose monitoring systems that include a monitor, control solution and… | 2008 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K113105 (Remote Diagnostic Technologies, Ltd., 2011) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K072369.
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 Myglucohealth glucose monitoring system provides a quick and easy way for diabetic patients to measure and self-monitor blood glucose levels. The system is comprised of the MGH-BT1 (w/Bluetooth wireless download capability) or the MGH-1 (w/o Bluetooth) blood glucose meter, control solution and test strips that carry a biosensor used for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the…
Read the full statement (169 words)
The Myglucohealth glucose monitoring system provides a quick and easy way for diabetic patients to measure and self-monitor blood glucose levels. The system is comprised of the MGH-BT1 (w/Bluetooth wireless download capability) or the MGH-1 (w/o Bluetooth) blood glucose meter, control solution and test strips that carry a biosensor used for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated, to allow for easy comparison to the laboratory method. Further, results from either meter may be uploaded to a memory device through a standard RS32 connection, or, with the -BTl model, wirelessly transmitted to a bluetooth capable PC or Cell phone. The Myglucohealth glucose monitoring systems are not to be used for the diagnosis or screening of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081703 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081703: Myglucohealth Glucose Monitoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081703
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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