510(k) · Cleared
ClearedLibre Rio Continuous Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care · SBH Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Cleared on Jun 7, 2024 as substantially equivalent to K222447 (Abbott Diabetes Care, Inc., 2023) after a 184-day review. Its family tree reaches back 5 generations to 2018. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 7, 2024
- Review
- 184 days
- Class
- Class II
- Product code
- SBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170088 (2018). No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 4 generations backK193371 FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020 · Recalled (Class I)
- 3 generations backK201761 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle…Abbott Diabetes Care, Inc. · 2021
- 2 generations backK210943 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle…Abbott Diabetes Care, Inc. · 2021
- 1 generation backK222447 FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3…Abbott Diabetes Care, Inc. · 2023
- This deviceK233861 Libre Rio Continuous Glucose Monitoring SystemAbbott Diabetes Care · 2024
Class I recalls in this family
- K193371 FreeStyle Libre 2 Flash Glucose Monitoring System4 generations back · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −4 | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2020 | Class I |
| −3 | K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021 | — |
| −2 | K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021 | — |
| −1 | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3… | Abbott Diabetes Care, Inc. | 2023 | — |
| 0 (this device) | K233861 | Libre Rio Continuous Glucose Monitoring System | Abbott Diabetes Care | 2024 | — |
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 K260935 Stelo Glucose Biosensor Systemscore 16.6 · 8 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 |
|---|---|---|---|
| * | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…Summary page 4…(s): SBH Review Panel: Clinical Chemistry 5.3 Predicate Device Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (K222447) Section 5 (Summary), Page 1 of 9… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 5 ancestors has a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K222447.
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. 2024, 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 Libre Rio Continuous Glucose Monitoring System is an over-the-counter (OTC) integrated continuous glucose monitoring (iCGM) device indicated for non-insulin using persons age 18 and older. The System detects trends and tracks patterns and aids in the detection of euglycemia, hyperglycemia, and hypoglycemia. The System is also intended to autonomously communicate with digitally connected devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233861: Libre Rio Continuous 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/K233861
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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