510(k) · Cleared
ClearedGlucoLeader Enhance Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hmd Biomedical, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 8, 2019 as substantially equivalent to K032985 (Hmd Biomedical, Inc., 2003) after a 244-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- May 8, 2019
- Review
- 244 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023279 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK023279 Glucoleader ValueHmd Biomedical, Inc. · 2003
- 1 generation backK032985 Glucoleader Enhance Self-Monitoring of Blood Glucose SystemHmd Biomedical, Inc. · 2003
- This deviceK182428 GlucoLeader Enhance Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK212248 GlucoLeader Enhance 2 Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K212248GlucoLeader Enhance 2 Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023279 | Glucoleader Value | Hmd Biomedical, Inc. | 2003 | — |
| −1 | K032985 | Glucoleader Enhance Self-Monitoring of Blood Glucose System | Hmd Biomedical, Inc. | 2003 | — |
| 0 (this device) | K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | Hmd Biomedical, Inc. | 2019 | — |
| +1 | K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | Hmd Biomedical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K032985 | Glucoleader Enhance Self-Monitoring of Blood Glucose SystemSummary page 4…Device Name GlucoLeader Enhance Self-Monitoring of Blood Glucose System 510(k) Number K032985 5-1 Your Partner in Blood Glucose Monitoring HMD BioMedical… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | 2022 | 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 16 years and passes through 1 company; a new generation was cleared every 15.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K212248 (Hmd Biomedical, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K032985.
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. 2019, 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 GlucoLeader Enhance Blood Glucose Monitoring System is comprised of GlucoLeader Enhance Blood Glucose Meter and GlucoLeader Enhance Blood Glucose Test Strips. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used by a single person…
Read the full statement (131 words)
The GlucoLeader Enhance Blood Glucose Monitoring System is comprised of GlucoLeader Enhance Blood Glucose Meter and GlucoLeader Enhance Blood Glucose Test Strips.
The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance Blood Glucose Monitoring System is not for use in neonates.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182428: GlucoLeader Enhance Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182428
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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