510(k) · Cleared
ClearedHealth Care System Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 13, 2011 as substantially equivalent to K070941 (Taidoc Technology Corporation, 2007) after a 39-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- May 13, 2011
- Review
- 39 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001907 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
- 1 generation backK070941 Clever Chek Health Care System Software, Version 1.0Taidoc Technology Corporation · 2007
- This deviceK110948 Health Care System SoftwareTaidoc Technology Corporation · 2011
- Descendant · cites it directly · 2 of its ownK113264 Electro Sensor Complex Software (ES Complex Software)Ld Technology, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK140412 ANS1 SoftwareLd Technology, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK130056 Patient MonitorLd Technology, LLC · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001907 | Camit Diabetes Management Software | Roche Diagnostics Corp. | 2000 | — |
| −1 | K070941 | Clever Chek Health Care System Software, Version 1.0 | Taidoc Technology Corporation | 2007 | — |
| 0 (this device) | K110948 | Health Care System Software | Taidoc Technology Corporation | 2011 | — |
| +1 | K113264 | Electro Sensor Complex Software (ES Complex Software) | Ld Technology, LLC | 2012 | — |
| +2 | K140412 | ANS1 Software | Ld Technology, LLC | 2014 | — |
| +2 | K130056 | Patient Monitor | Ld Technology, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K070941 | Clever Chek Health Care System Software, Version 1.0Summary page 1…Chek Health Care System Software Common/Usual Name: Data management software Submitter TaiDoc Technology Corporation 510 (k) Number K070941 4. Device Description The Health Care System Software is an optional software accessory for use with the followin… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113264 | Electro Sensor Complex Software (ES Complex Software) | 2012 | 2 |
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 11 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113264 (Ld Technology, LLC, 2012) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K070941.
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. 2011, 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 Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
The Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110948 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110948: Health Care System Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110948
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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