510(k) · Cleared
ClearedGlooko Device System for Glooko Logbook+ Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glooko, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 25, 2013 as substantially equivalent to K122142 (Glooko, Inc., 2012) after a 27-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it.
- Decided
- Apr 25, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K861844 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK861844 Glucofacts Data Management SystemMiles Laboratories, Inc. · 1986
- 3 generations backK024234 Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp. · 2003
- 2 generations backK082486 Glucofacts Express Diabetes Management SoftwareBayer Healthcare, LLC · 2008
- 1 generation backK122142 Glooko Logbook ChartsGlooko, Inc. · 2012
- This deviceK130886 Glooko Device System for Glooko Logbook+ ApplicationGlooko, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK141862 HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableH2, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK132272 Glooko Device System for Glooko ApplicationGlooko, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861844 | Glucofacts Data Management System | Miles Laboratories, Inc. | 1986 | — |
| −3 | K024234 | Ascensia Glucofacts; Ascensia Glucofacts Professional | Bayer Corp. | 2003 | — |
| −2 | K082486 | Glucofacts Express Diabetes Management Software | Bayer Healthcare, LLC | 2008 | — |
| −1 | K122142 | Glooko Logbook Charts | Glooko, Inc. | 2012 | — |
| 0 (this device) | K130886 | Glooko Device System for Glooko Logbook+ Application | Glooko, Inc. | 2013 | — |
| +1 | K141862 | HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart Cable | H2, Inc. | 2014 | — |
| +1 | K132272 | Glooko Device System for Glooko Application | Glooko, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 |
|---|---|---|---|
| * | K122142 | Glooko Logbook ChartsSummary page 1…NBW and JQP Equivalent Device: Glooko Device System for Glooko Logbook Application and Glooko Logbook Charts (K1 22142) Device Description: Overview The Glooko device system for Glooko Logbook+ Application is used to aid individuals with diabete… | 2012 |
What descends from it? (2)
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 27 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K141862 (H2, Inc., 2014) has gone furthest, with 0 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. 2013, 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 Glooko device system for Glooko Logbook+ Application is a data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Logbook+ Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform.
The Glooko device system for Glooko Logbook+ Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130886: Glooko Device System for Glooko Logbook+ Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130886
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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