Chrysalis Intelligence · Product Codes · SAF

SAF · Unclassified

4 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
4
2024-03-05 → 2026-05-21
Last 12 months
1
Unique sponsors
3
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Dexcom, Inc. 2 1 2026-05-21
Signos, Inc. 1 0 2025-03-21
Abbott 1 0 2024-05-29
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
95250 CPT High CPT for continuous glucose monitoring system setup and initiation, standard for CGM devices
95251 CPT High CPT for continuous glucose monitoring system data interpretation and report, applicable to monitoring
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-21 K261359 Dexcom, Inc. Stelo Glucose Biosensor System
2025-03-21 K250106 Signos, Inc. Signos Glucose Monitoring System
2024-05-29 K233655 Abbott Lingo Glucose System
2024-03-05 K234070 Dexcom, Inc. Stelo Glucose Biosensor System