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. · SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Cleared on Mar 5, 2024 as substantially equivalent to K231081 (Dexcom, Inc., 2023) after a 74-day review. Its family tree reaches back 7 generations to 2018. 1 of the 14 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Mar 5, 2024
- Review
- 74 days
- Class
- Class II
- Product code
- SAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN170088 (2018). 9 ancestors in all. 4 later devices descend from it, 3 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 6 generations backK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 5 generations backK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019 · Recalled
- 4 generations backK200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2020 · Recalled
- 3 generations backK201328 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021
- 2 generations backK213919 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · Recalled (Class I)
- 1 generation backK231081 Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · Recalled
- This deviceK234070 Stelo Glucose Biosensor SystemDexcom, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK260935 Stelo Glucose Biosensor SystemDexcom, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK262472 Stelo Glucose Biosensor SystemDexcom, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK261359 Stelo Glucose Biosensor SystemDexcom, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250106 Signos Glucose Monitoring SystemSignos, Inc. · 2025
Class I recalls in this family
- K213919 Dexcom G7 Continuous Glucose Monitoring System2 generations back · 2022
Most influential descendants
Showing 4 of 4 · See all- K260935Stelo Glucose Biosensor SystemDexcom, Inc. · 2026 · cites it directly1descendant
- K262472Stelo Glucose Biosensor SystemDexcom, Inc. · 2026 · 2 generations on0descendants
- K261359Stelo Glucose Biosensor SystemDexcom, Inc. · 2026 · cites it directly0descendants
- K250106Signos Glucose Monitoring SystemSignos, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −6 | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −5 | K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2019 | 2 |
| −4 | K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2020 | 1 |
| −3 | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021 | — |
| −2 | K213919 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2022 | Class I |
| −1 | K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023 | 1 |
| 0 (this device) | K234070 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2024 | — |
| +1 | K260935 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026 | — |
| +2 | K262472 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026 | — |
| +1 | K261359 | Stelo Glucose Biosensor System | Dexcom, Inc. | 2026 | — |
| +1 | K250106 | Signos Glucose Monitoring System | Signos, Inc. | 2025 | — |
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 |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 3 | 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 SAF device
- #1 K261359 Stelo Glucose Biosensor Systemscore 13.5 · 8 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 |
|---|---|---|---|
| * | K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) SystemSummary page 5…Over-The-Counter Regulation Number 862.1355 Product Code(s) SAF LEGALLY MARKETED PREDICATE DEVICES Predicate # K231081 Predicate Trade Name Dexcom G7 Continuous Glucose Monitoring System Product Code QBJ === Page… | 2023 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 4 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K260935 (Dexcom, Inc., 2026) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K231081.
How does its category compare?
All SAF devicesSAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SAF
Too few SAF 510(k)s in any year since 2007 to give a median.
Recalls per year · SAF
No recall names SAF since 2007.
Adverse event reports per year · SAF
1,481in 2025
MAUDE reports naming product code SAF, 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 | 2 | — | 0 | 249 |
| 2025 | 1 | — | 0 | 1,481 |
| 2026 | 1 | — | 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 18 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.
The user is not intended to take medical action based on the device output without consultation with a qualified healthcare
professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K234070: Stelo Glucose Biosensor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K234070
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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