Lingo Glucose System

Q: What is the product code of K233655?

The FDA product code is SAF – Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1355.

FDA 510(k) K233655 · Abbott

Substantially Equivalent

510(k) numberK233655

Submission

Device name: Lingo Glucose System
Applicant: Abbott
Alameda, CA, US
Received: November 14, 2023
Decision date: May 29, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: SAF – Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1355
Specialty: Clinical Chemistry

An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive…

Other 510(k)s with product code SAF

510(k)	Device	Applicant	Decision
K261359	Stelo Glucose Biosensor SystemSAF · Special	Dexcom, Inc.	05/21/2026SE
K250106	Signos Glucose Monitoring SystemSAF · Traditional	Signos, Inc.	03/21/2025SE
K234070	Stelo Glucose Biosensor SystemSAF · Traditional	Dexcom, Inc.	03/05/2024SE

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Questions and answers

When was Lingo Glucose System cleared by the FDA?

Lingo Glucose System (K233655) received a 510(k) decision of Substantially Equivalent on May 29, 2024, 197 days after the submission was received.

What is the product code of K233655?

The FDA product code is SAF – Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1355.