510(k) · Cleared
ClearedSmartlink Gold Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Diagnostics, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 9, 2010 as substantially equivalent to K082683 (Standard Diagnostics, Inc., 2009) after a 113-day review. Its family tree reaches back 2 generations to 2003. 5 later devices descend from it.
- Decided
- Jun 9, 2010
- Review
- 113 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K024194 (2003). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 1 generation backK082683 SD Check GoldStandard Diagnostics, Inc. · 2009
- This deviceK100398 Smartlink Gold Blood Glucose Monitoring SystemStandard Diagnostics, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK132929 SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and…Sd Biosensor, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK123517 Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood…Sd Biosensor · 2014
- Descendant · cites it directly · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
- Descendant · 2 generations on · 0 of its ownK153201 SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD…Sd Biosensor · 2016
- Descendant · 2 generations on · 0 of its ownK151265 SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood…Sd Biosensor · 2015
Most influential descendants
Showing 5 of 5 · See all- K132929SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor…Sd Biosensor, Inc. · 2015 · cites it directly1descendant
- K123517Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring…Sd Biosensor · 2014 · cites it directly1descendant
- K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · cites it directly0descendants
- K153201SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi…Sd Biosensor · 2016 · 2 generations on0descendants
- K151265SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring…Sd Biosensor · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −1 | K082683 | SD Check Gold | Standard Diagnostics, Inc. | 2009 | — |
| 0 (this device) | K100398 | Smartlink Gold Blood Glucose Monitoring System | Standard Diagnostics, Inc. | 2010 | — |
| +1 | K132929 | SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD… | Sd Biosensor, Inc. | 2015 | — |
| +1 | K123517 | Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose… | Sd Biosensor | 2014 | — |
| +1 | K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT… | Sd Biosensor | 2017 | — |
| +2 | K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor… | Sd Biosensor | 2016 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K082683 | SD Check GoldSummary page 2…e 2 === 3. Common or Usual Name: Blood-Glucose Test System, Over-the-Counter 4. Predicate Device Information: SD CHECK GOLD Blood Glucose Monitoring System, K082683 S. Device Description: The SmartLink TM GOLD Blood Glucose System is an RxIOTC blood glucose systemn to be used b… | 2009 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132929 | SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor… | 2015 | 1 |
| K123517 | Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring… | 2014 | 1 |
| K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT… | 2017 | 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 7 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K132929 (Sd Biosensor, Inc., 2015) has gone furthest, with 1 descendant of its own.
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. 2010, 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?
SmartLinkTm GOLD blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SmartLink TM GOLD meter must be used with SmartLink'T m GOLD blood glucose test strip and SD Control solutions. The SD control solutions Level M and Level H are for use with SmartLink Tm GOLD test system as quality controls to verify the accuracy of blood glucose test results.…
Read the full statement (131 words)
SmartLinkTm GOLD blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SmartLink TM GOLD meter must be used with SmartLink'T m GOLD blood glucose test strip and SD Control solutions.
The SD control solutions Level M and Level H are for use with SmartLink Tm GOLD test system as quality controls to verify the accuracy of blood glucose test results.
Testing is done outside the body (in vitro diagnostic use).
This system is indicated for home (over-the-counter, OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
This system should not be used for the screening or diagnosis of diabetes or for testing neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100398: Smartlink Gold 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/K100398
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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