510(k) · Cleared
ClearedGlucobalance Data Management Software, Model 555020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hypoguard USA, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Oct 11, 2002 as substantially equivalent to K001907 (Roche Diagnostics Corp., 2000) after a 71-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Oct 11, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001907 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
- This deviceK022545 Glucobalance Data Management Software, Model 555020Hypoguard USA, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK093819 Arkray Diabetes Data Management Software (SMBG Viewer)Arkray Factory USA, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093819Arkray Diabetes Data Management Software (SMBG Viewer)Arkray Factory USA, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001907 | Camit Diabetes Management Software | Roche Diagnostics Corp. | 2000 | — |
| 0 (this device) | K022545 | Glucobalance Data Management Software, Model 555020 | Hypoguard USA, Inc. | 2002 | — |
| +1 | K093819 | Arkray Diabetes Data Management Software (SMBG Viewer) | Arkray Factory USA, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K001907 | Camit Diabetes Management Software | 2000 |
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 |
|---|---|---|---|
| K093819 | Arkray Diabetes Data Management Software (SMBG Viewer) | 2010 | 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?
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.
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?
Intended Use: GlucoBalanceTM Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. GlucoBalance transfers data from the meter's memory into a computer for enhanced data management. GlucoBalance is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022545: Glucobalance Data Management Software, Model 555020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022545
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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