510(k) · Cleared
ClearedGlucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sd Biosensor · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jan 17, 2014 as substantially equivalent to K100398 (Standard Diagnostics, Inc., 2010) after a 429-day review. Its family tree reaches back 3 generations to 2003. 1 later device descends from it.
- Decided
- Jan 17, 2014
- Review
- 429 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K024194 (2003). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 2 generations backK082683 SD Check GoldStandard Diagnostics, Inc. · 2009
- 1 generation backK100398 Smartlink Gold Blood Glucose Monitoring SystemStandard Diagnostics, Inc. · 2010
- This deviceK123517 Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood…Sd Biosensor · 2014
- Descendant · cites it directly · 0 of its ownK151265 SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood…Sd Biosensor · 2015
Most influential descendants
Showing 1 of 1 · See all- K151265SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring…Sd Biosensor · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −2 | K082683 | SD Check Gold | Standard Diagnostics, Inc. | 2009 | — |
| −1 | K100398 | Smartlink Gold Blood Glucose Monitoring System | Standard Diagnostics, Inc. | 2010 | — |
| 0 (this device) | K123517 | Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose… | Sd Biosensor | 2014 | — |
| +1 | K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose… | Sd Biosensor | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K100398 | Smartlink Gold Blood Glucose Monitoring SystemSummary page 1…CRIPTION: : SD GlucoMentor™ : Blood Glucose Monitoring System :21 CFR §862.1345 : Blood Glucose Test System, Over the Counter :NBW :CGA/IIX : 11 Predicate Device K100398 SmartLink™ Gold SD GlucoMentor™ blood glucose system is an Rx/OTC blood glucose monitoring system to be used 10f4 === Page 2 =… | 2010 |
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 |
|---|---|---|---|
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring… | 2015 | 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K151265 (Sd Biosensor, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K100398.
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?
The SD GlucoMentor multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoMentor multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of…
Read the full statement (162 words)
The SD GlucoMentor multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoMentor multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices.
The SD GlucoMentor multi Bleod Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use, Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The SD GlucoMentor multi Blood Glucose Test Strips are for use with the SD GlucoMentor multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123517: Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123517
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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