510(k) · Cleared
ClearedGlucofacts Express Diabetes Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Oct 8, 2008 as substantially equivalent to K024234 (Bayer Corp., 2003) after a 41-day review. Its family tree reaches back 2 generations to 1986. 5 later devices descend from it.
- Decided
- Oct 8, 2008
- Review
- 41 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861844 (1986). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK861844 Glucofacts Data Management SystemMiles Laboratories, Inc. · 1986
- 1 generation backK024234 Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp. · 2003
- This deviceK082486 Glucofacts Express Diabetes Management SoftwareBayer Healthcare, LLC · 2008
- Descendant · cites it directly · 3 of its ownK122142 Glooko Logbook ChartsGlooko, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK130886 Glooko Device System for Glooko Logbook+ ApplicationGlooko, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK141862 HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableH2, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK132272 Glooko Device System for Glooko ApplicationGlooko, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK093930 Didget World ReportsBayer Healthcare, LLC · 2010
Most influential descendants
Showing 5 of 5 · See all- K122142Glooko Logbook ChartsGlooko, Inc. · 2012 · cites it directly3descendants
- K130886Glooko Device System for Glooko Logbook+ ApplicationGlooko, Inc. · 2013 · 2 generations on2descendants
- K141862HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableH2, Inc. · 2014 · 3 generations on0descendants
- K132272Glooko Device System for Glooko ApplicationGlooko, Inc. · 2013 · 3 generations on0descendants
- K093930Didget World ReportsBayer Healthcare, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861844 | Glucofacts Data Management System | Miles Laboratories, Inc. | 1986 | — |
| −1 | K024234 | Ascensia Glucofacts; Ascensia Glucofacts Professional | Bayer Corp. | 2003 | — |
| 0 (this device) | K082486 | Glucofacts Express Diabetes Management Software | Bayer Healthcare, LLC | 2008 | — |
| +1 | K122142 | Glooko Logbook Charts | Glooko, Inc. | 2012 | — |
| +2 | K130886 | Glooko Device System for Glooko Logbook+ Application | Glooko, Inc. | 2013 | — |
| +3 | K141862 | HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart Cable | H2, Inc. | 2014 | — |
| +3 | K132272 | Glooko Device System for Glooko Application | Glooko, Inc. | 2013 | — |
| +1 | K093930 | Didget World Reports | Bayer Healthcare, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K024234 | Ascensia Glucofacts; Ascensia Glucofacts ProfessionalSummary page 1…nd Toxicology Classification Code - 75 NBW, JQP Predicate Device: Ascensia® Glucofacts® Data Management System, k024234 Device Description: This software application allows the transfer of blood glucose results, along… | 2003 |
What descends from it? (5)
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 22 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122142 (Glooko, Inc., 2012) has gone furthest, with 3 descendants of its own.
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?
GLUGOFACTS ® Express Diabetes Management Software is an over-the-counter software program for use by persons with diabetes in the home and by healthcare professionals in healthcare facilities to assist with transferring blood glucose data from a blood glucose monitor to a personal computer to allow reviewing and analyzing the data to support effective diabetes management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082486 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082486: Glucofacts Express Diabetes Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082486
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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