510(k) · Cleared
ClearedStelo Glucose Biosensor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dexcom, Inc. · SBH Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Cleared on Jun 12, 2026 as substantially equivalent to K234070 (Dexcom, Inc., 2024) after an 84-day review. Its family tree reaches back 8 generations to 2018. 1 of the 12 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 12, 2026
- Review
- 84 days
- Class
- Class II
- Product code
- SBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to DEN170088 (2018). 10 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 7 generations backK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 6 generations backK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019 · Recalled
- 5 generations backK200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2020 · Recalled
- 4 generations backK201328 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021
- 3 generations backK213919 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · Recalled (Class I)
- 2 generations backK231081 Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · Recalled
- 1 generation backK234070 Stelo Glucose Biosensor SystemDexcom, Inc. · 2024
- This deviceK260935 Stelo Glucose Biosensor SystemDexcom, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK262472 Stelo Glucose Biosensor SystemDexcom, Inc. · 2026
Class I recalls in this family
- K213919 Dexcom G7 Continuous Glucose Monitoring System3 generations back · 2022
Most influential descendants
Showing 1 of 1 · See all- K262472Stelo Glucose Biosensor SystemDexcom, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −7 | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −6 | K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2019 | 2 |
| −5 | K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2020 | 1 |
| −4 | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021 | — |
| −3 | K213919 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2022 | Class I |
| −2 | K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023 | 1 |
| −1 | K234070 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2024 | — |
| 0 (this device) | K260935 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026 | — |
| +1 | K262472 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
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 SBH device
- #1 K262472 Stelo Glucose Biosensor Systemscore 14.2 · 9 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K234070 | Stelo Glucose Biosensor SystemSummary page 6…ibrated Regulation Number 21 CFR 862.1355 Product Code SBH Legally Marketed Predicate Device: Predicate # K234070 Predicate Trade Name Stelo Glucose Biosensor System Product Code SAF Legally Marketed Reference De… | 2024 |
| † | K213919 | Dexcom G7 Continuous Glucose Monitoring System | 2022 |
| † | K234133 | Dexcom G7 Continuous Glucose Monitoring System | 2024 |
| † | K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | 2025 |
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 |
|---|---|---|---|
| K262472 | Stelo Glucose Biosensor System | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · 3 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 4 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K262472 (Dexcom, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K234070.
How does its category compare?
All SBH devicesSBH Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SBH
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SBH
Too few SBH 510(k)s in any year since 2007 to give a median.
Recalls per year · SBH
No recall names SBH since 2007.
Adverse event reports per year · SBH
1in 2025
MAUDE reports naming product code SBH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze, and display glucose values in people 2 years and older not on insulin. The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260935: Stelo Glucose Biosensor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260935
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026