Chrysalis Intelligence · Product Codes · QBJ

QBJ · Integrated Continuous Glucose Monitoring System, Factory Calibrated

Clinical Chemistry · 15 clearances · 2 unique sponsors

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Device class
Class II
Regulation 862.1355
Total clearances
15
2020-12-04 → 2026-06-08
Last 12 months
3
Unique sponsors
2
Definition

What is Integrated Continuous Glucose Monitoring System, Factory Calibrated

An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.
Classification details
Medical specialty
Clinical Chemistry
Review panel
CH
Regulation number
862.1355
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Dexcom, Inc. 12 3 2026-06-08
Abbott Diabetes Care, Inc. 3 0 2024-04-23
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 Continuous glucose monitoring system setup and patient training
95251 CPT — High Continuous glucose monitoring system; sensor placement and 14-day supply
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-08 K261402 Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System
2026-02-03 K253737 Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
2025-12-17 K253710 Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
2025-04-09 K243214 Dexcom, Inc. Dexcom G7 15 Day Continuous Glucose Monitoring System
2024-04-23 K240902 Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring System
2024-04-23 K233537 Abbott Diabetes Care, Inc. FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
2024-02-26 K234133 Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring System
2023-05-15 K231081 Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring (CGM) System
2023-04-13 K223435 Abbott Diabetes Care, Inc. FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
2023-03-03 K222447 Abbott Diabetes Care, Inc. FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
2023-01-11 K223931 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring (CGM) System
2022-12-07 K213919 Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring System
2022-07-29 K221259 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
2021-07-15 K201328 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring (CGM) System
2020-12-04 K200876 Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence