Product code SAF— 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 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.”

FDA has cleared 4 devices under product code SAF between 2024 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20251 clearance
• 20242 clearances

• Dexcom, Inc.2 clearances
• Signos, Inc.1 clearance
• Abbott1 clearance

Injury

164

Malfunction

1,935

Total

2,099

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K261359 — Stelo Glucose Biosensor SystemDexcom, Inc.·2026-05-21
• K250106 — Signos Glucose Monitoring SystemSignos, Inc.·2025-03-21
• K233655 — Lingo Glucose SystemAbbott·2024-05-29
• K234070 — Stelo Glucose Biosensor SystemDexcom, Inc.·2024-03-05