510(k) · Cleared
ClearedEvolution Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hmd Biomedical, LLC · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Mar 21, 2008 as substantially equivalent to K021819 (Lifescan, Inc., 2002) after a 211-day review. Its family tree reaches back 2 generations to 1995. 21 later devices descend from it.
- Decided
- Mar 21, 2008
- Review
- 211 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950727 (1995). 3 ancestors in all. 21 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
- 1 generation backK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · Recalled
- This deviceK072369 Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008
- Descendant · cites it directly · 10 of its ownK081703 Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 2009
- Descendant · 2 generations on · 8 of its ownK113105 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011
- Descendant · 3 generations on · 7 of its ownK152124 Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015
- Descendant · 4 generations on · 6 of its ownK152645 Dictum HealthDictum Health, Inc. · 2016
- Descendant · 5 generations on · 5 of its ownK170798 Dictum HealthDictum Health, Inc. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 2009 · cites it directly10descendants
- K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011 · 2 generations on8descendants
- K152124Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015 · 3 generations on7descendants
- K152645Dictum HealthDictum Health, Inc. · 2016 · 4 generations on6descendants
- K170798Dictum HealthDictum Health, Inc. · 2017 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950727 | One Touch Profile Complete Diabetes Tracking System | Lifescan, Inc. | 1995 | — |
| −1 | K021819 | One Touch Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | 2002 | 1 |
| 0 (this device) | K072369 | Evolution Blood Glucose Monitoring System | Hmd Biomedical, LLC | 2008 | — |
| +1 | K081703 | Myglucohealth Glucose Monitoring Systems | Entra Health Systems, Ltd. | 2009 | — |
| +2 | K113105 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2011 | — |
| +3 | K152124 | Tempus IC2 | Remote Diagnostics Technologies, Ltd. | 2015 | — |
| +4 | K152645 | Dictum Health | Dictum Health, Inc. | 2016 | — |
| +5 | K170798 | Dictum Health | Dictum Health, Inc. | 2017 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 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 |
|---|---|---|---|
| * | K021819 | One Touch Ultrasmart Blood Glucose Monitoring SystemSummary page 1…NBW, CGA, JJX 3. Predicate Device: We claim substantial equivalence to the LifeScan One Touch® Ultra ® Blood Glucose Monitoring System (K021819) By LifeScan Inc. 4. Description: The EvolutionTM Monitor is an in vitro diagnostic device designed for meas… | 2002 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081703 | Myglucohealth Glucose Monitoring Systems | 2009 | 10 |
| K103021 | Element Plus Blood Glucose Monitoring System | 2011 | 3 |
| K082275 | Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023 | 2010 | 2 |
| K090405 | Lipidpro System | 2009 | 1 |
| K113764 | Glucose Meter-Check Solution for Infopia | 2012 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K081703 (Entra Health Systems, Ltd., 2009) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K021819.
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. 2008, 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 EvolutionTM Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. EvolutionTM Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis 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/K072369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072369: Evolution Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072369
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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