510(k) · Cleared
ClearedHEALTH2SYNC Mobile Application, HEALTH2SYNC Smart Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H2, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Dec 2, 2014 as substantially equivalent to K130886 (Glooko, Inc., 2013) after a 145-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Dec 2, 2014
- Review
- 145 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K861844 (1986). No later device cites it as a predicate yet.
- Root · 5 generations backK861844 Glucofacts Data Management SystemMiles Laboratories, Inc. · 1986
- 4 generations backK024234 Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp. · 2003
- 3 generations backK082486 Glucofacts Express Diabetes Management SoftwareBayer Healthcare, LLC · 2008
- 2 generations backK122142 Glooko Logbook ChartsGlooko, Inc. · 2012
- 1 generation backK130886 Glooko Device System for Glooko Logbook+ ApplicationGlooko, Inc. · 2013
- This deviceK141862 HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableH2, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861844 | Glucofacts Data Management System | Miles Laboratories, Inc. | 1986 | — |
| −4 | K024234 | Ascensia Glucofacts; Ascensia Glucofacts Professional | Bayer Corp. | 2003 | — |
| −3 | K082486 | Glucofacts Express Diabetes Management Software | Bayer Healthcare, LLC | 2008 | — |
| −2 | K122142 | Glooko Logbook Charts | Glooko, Inc. | 2012 | — |
| −1 | K130886 | Glooko Device System for Glooko Logbook+ Application | Glooko, Inc. | 2013 | — |
| 0 (this device) | K141862 | HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart Cable | H2, Inc. | 2014 | — |
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 |
|---|---|---|---|
| * | K130886 | Glooko Device System for Glooko Logbook+ ApplicationSummary page 7…below. Name: Glooko Device System for Glooko Logbook+ Application Device Company: Glooko, Inc. 510(K) Number: K130886 7. Specification Comparison to Predicate Devices: Similarities and Differences… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K130886.
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. 2014, 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?
Health2Sync Mobile Application is data management software that is intended for use in home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. The Health2Sync Smart Cable allows users to upload blood glucose data from compatible FDA cleared meters to the Health2Sync Mobile Application on their iPhone operating system platform.
Health2Sync Mobile Application is not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141862: HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141862
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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