510(k) · Cleared
Recalled · Class I · 2014Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Broadmaster Biotech Corperation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 11, 2012 as substantially equivalent to K102316 (Broadmaster Biotech Corporation, 2011) after a 109-day review. Its family tree reaches back 2 generations to 2007. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- May 11, 2012
- Review
- 109 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K072039 (2007). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK072039 Advocate Redi-Code Blood Glucose Monitoring System, Models TD-4223E…Taidoc Technology Corporation · 2007
- 1 generation backK102316 Glucose Shepherd Blood Glucose Monitoring SystemBroadmaster Biotech Corporation · 2011
- This deviceK120183 Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring SystemBroadmaster Biotech Corperation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K072039 | Advocate Redi-Code Blood Glucose Monitoring System, Models TD-4223E; TD-4223F | Taidoc Technology Corporation | 2007 | — |
| −1 | K102316 | Glucose Shepherd Blood Glucose Monitoring System | Broadmaster Biotech Corporation | 2011 | — |
| 0 (this device) | K120183 | Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring System | Broadmaster Biotech Corperation | 2012 | — |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K102316 | Glucose Shepherd Blood Glucose Monitoring SystemSummary page 3…ndidate device Predicate device Item ADVOCATE* Redi-Code+ BMB-EAOO IS Blood Glucose k102316 Monitoring System Appearance Intended use Same for… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2014 | Class I | Z-2021-2014 | Labeling False and Misleading | "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 2 ancestors has a recall.
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. 2012, 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?
ADVOCATE® Redi-Code+ BMB-EAOO IS Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper aim, the calf, and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The ADVOCATE® Redi-Code~ BMB-EAOO1 S Blood Glucose…
Read the full statement (242 words)
ADVOCATE® Redi-Code+ BMB-EAOO IS Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper aim, the calf, and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The ADVOCATE® Redi-Code~ BMB-EAOO1 S Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In additional, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control programn. It should not be used for the diagnosis of diabetes, or for the testing of neonates.
The ADVOCATE®0 Redi-Code+ BMB-EAOO 1S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EAOOlIS Blood Glucose meter and the AD VOCATE® Redi-Code+ BMB-BAOO6A Blood Glucose test strips. The ADVOCATE® Redi-Code+ BMB-EAOOI S meter are used only with ADVOCATE® Redi-Code+ BMB-BA006A Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh. The meter also included speaking functions but has not been validated for use by the visually impaired.
The ADVOCATE® Redi-Code+ control solutions are for use with the ADVOCATE® Redi-Code+ BMIB-EAOO1 S Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120183 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120183: Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120183
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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