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SAFClass II

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

21 CFR 862.1355 / Clinical Chemistry
FDA source (opens on fda.gov)

SAF is the FDA product code for Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter, a class II device type, regulated under 21 CFR 862.1355. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SAF
Device name
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
FDA definition
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 glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional.
Regulation
21 CFR 862.1355
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code SAF

By decision year
4 clearances under product code SAF with a decision year between 2024 and 2026, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SAF by decision year
YearClearances
20242
20251
20261

Applicants with the most clearances

Product code SAF
Applicants holding the most 510(k) clearances under product code SAF
ApplicantClearances
Dexcom, Inc.2
Abbott Medical1
Signos, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order