510(k) · Cleared
ClearedLingo Glucose System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott · SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Cleared on May 29, 2024 as substantially equivalent to K222447 (Abbott Diabetes Care, Inc., 2023) after a 197-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
- May 29, 2024
- Review
- 197 days
- Class
- Class II
- Product code
- SAF
- 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 deviceK233655 Lingo Glucose SystemAbbott · 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) | K233655 | Lingo Glucose System | Abbott | 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 SAF device
- #1 K234070 Stelo Glucose Biosensor Systemscore 17.8 · 7 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 |
|---|---|---|---|
| * | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…Summary page 4…tion: Class II Review Panel: Clinical Chemistry Predicate Device Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (K222447) 510(k) 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 1.2 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 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 Lingo Glucose 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 Lingo Glucose System helps to detect euglycemic and dysglycemic glucose levels. The Lingo Glucose 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/K233655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233655: Lingo Glucose System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233655
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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