510(k) · Cleared
ClearedGlucofacts Data Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miles Laboratories, Inc. · JQP Calculator/Data Processing Module, For Clinical Use
Cleared on Aug 12, 1986 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Aug 12, 1986
- Review
- 91 days
- Class
- Class I
- Product code
- JQP
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK861844 Glucofacts Data Management SystemMiles Laboratories, Inc. · 1986
- Descendant · cites it directly · 6 of its ownK024234 Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp. · 2003
- Descendant · 2 generations on · 5 of its ownK082486 Glucofacts Express Diabetes Management SoftwareBayer Healthcare, LLC · 2008
- Descendant · 3 generations on · 3 of its ownK122142 Glooko Logbook ChartsGlooko, Inc. · 2012
- Descendant · 4 generations on · 2 of its ownK130886 Glooko Device System for Glooko Logbook+ ApplicationGlooko, Inc. · 2013
- Descendant · 5 generations on · 0 of its ownK141862 HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableH2, Inc. · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K024234Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp. · 2003 · cites it directly6descendants
- K082486Glucofacts Express Diabetes Management SoftwareBayer Healthcare, LLC · 2008 · 2 generations on5descendants
- K122142Glooko Logbook ChartsGlooko, Inc. · 2012 · 3 generations on3descendants
- K130886Glooko Device System for Glooko Logbook+ ApplicationGlooko, Inc. · 2013 · 4 generations on2descendants
- K141862HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableH2, Inc. · 2014 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861844 | Glucofacts Data Management System | Miles Laboratories, Inc. | 1986 | — |
| +1 | K024234 | Ascensia Glucofacts; Ascensia Glucofacts Professional | Bayer Corp. | 2003 | — |
| +2 | K082486 | Glucofacts Express Diabetes Management Software | Bayer Healthcare, LLC | 2008 | — |
| +3 | K122142 | Glooko Logbook Charts | Glooko, Inc. | 2012 | — |
| +4 | K130886 | Glooko Device System for Glooko Logbook+ Application | Glooko, Inc. | 2013 | — |
| +5 | K141862 | HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart Cable | H2, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024234 | Ascensia Glucofacts; Ascensia Glucofacts Professional | 2003 | 6 |
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?
- Of its descendants, K024234 (Bayer Corp., 2003) has gone furthest, with 6 descendants of its own.
How does its category compare?
All JQP devicesJQP Calculator/Data Processing Module, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JQP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JQP
Too few JQP 510(k)s in any year since 2007 to give a median.
Recalls per year · JQP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JQP
113in 2025
MAUDE reports naming product code JQP, 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 | 0 | — | 3 | 22 |
| 2008 | 0 | — | 6 | 9 |
| 2009 | 0 | — | 9 | 14 |
| 2010 | 0 | — | 7 | 45 |
| 2011 | 0 | — | 9 | 128 |
| 2012 | 1 | — | 6 | 102 |
| 2013 | 0 | — | 5 | 46 |
| 2014 | 0 | — | 3 | 85 |
| 2015 | 0 | — | 10 | 142 |
| 2016 | 0 | — | 12 | 204 |
| 2017 | 0 | — | 2 | 110 |
| 2018 | 0 | — | 10 | 218 |
| 2019 | 0 | — | 2 | 253 |
| 2020 | 0 | — | 2 | 52 |
| 2021 | 0 | — | 0 | 105 |
| 2022 | 0 | — | 3 | 166 |
| 2023 | 0 | — | 0 | 171 |
| 2024 | 0 | — | 5 | 102 |
| 2025 | 0 | — | 1 | 113 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K861844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K861844: Glucofacts Data Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K861844
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026