510(k) · Cleared
ClearedBroadmaster Healthcare System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Broadmaster Biotech Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 30, 2013 as substantially equivalent to K070941 (Taidoc Technology Corporation, 2007) after a 144-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jul 30, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001907 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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…ftware Common Name Clever Check Health System Software Manufacturer Taifloc Technology Corporation 5 10(k) Number k070941I 4. Device Description The BroadMaster HealthCare System is a software designed to collect user glucose raw data, analyze… | 2007 |
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 13 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 2 ancestors has a recall.
- 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. 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 BroadMaster HealthCare Systemn is a software accessory compatible with legally marketed BroadMaster Biotech glucose meters, Such as the Glucose Shepherd Blood Glucose Monitoring System and ADVOGATEO Redi-Gode* B3MB-EA001 S Blood Glucose Monitoring System and is intended for use in the home setting by people with diabetes. Ftis intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The BroadMaster…
Read the full statement (111 words)
The BroadMaster HealthCare Systemn is a software accessory compatible with legally marketed BroadMaster Biotech glucose meters, Such as the Glucose Shepherd Blood Glucose Monitoring System and ADVOGATEO Redi-Gode* B3MB-EA001 S Blood Glucose Monitoring System and is intended for use in the home setting by people with diabetes. Ftis intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The BroadMaster HealthCare System receives via USS, stores, and uses patient data for display and reporting, sets meter date, lime and alarm. The software is designed (or multiple users use and only compatible with) personal computer. It's not compatible with other devices such as PDAs or smartphones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130621 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130621: Broadmaster Healthcare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130621
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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