# K233655: Lingo Glucose System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott
- Decided: May 29, 2024 after 197 days
- Product code: SAF (Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 862.1355
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN170088 (2018). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222447: FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System, Abbott Diabetes Care, Inc. (2023) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K233655
Methodology: https://510kreport.com/methodology