QJI · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-06-16 → 2026-07-09

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Insulet Corporation	6	2	2026-06-29
Tandem Diabetes Care, Inc.	5	1	2026-04-24
Medtronic Minimed	4	4	2026-07-09
Beta Bionics, Inc.	2	0	2023-09-22
Diabeloop	1	1	2025-12-19
Deka Research and Development	1	0	2024-03-13
Camdiab , Ltd.	1	0	2024-05-23
Tidepool Project	1	0	2023-01-23

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.

Code	Type	Description	Confidence	Rationale
95250	CPT	—	High	Continuous glucose monitoring; glucose monitoring with automated controller
95251	CPT	—	High	Continuous glucose monitoring system; automated glycemic control with CGM integration
E0607	HCPCS	Home blood glucose monitor ✓ CMS-verified description	High	Insulin infusion pump; durable medical equipment code for interoperable automated delivery

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-09	K261962	Medtronic MiniMed	SmartGuard Technology; Predictive Low Glucose Technology
2026-06-29	K261461	Insulet Corporation	Omnipod 6 algorithm
2026-04-24	K260429	Tandem Diabetes Care, Inc.	Control-IQ+ technology
2026-02-03	K253701	Medtronic Minimed	SmartGuard Technology; Predictive Low Glucose Technology
2026-01-14	K253585	Medtronic Minimed, Inc.	SmartGuard technology; Predictive Low Glucose technology
2025-12-19	K251152	Diabeloop	DBLG2
2025-12-03	K251779	Insulet Corporation	Omnipod 5 algorithm
2025-08-29	K251217	Medtronic Minimed, Inc.	SmartGuard technology; Predictive Low Glucose technology
2025-05-21	K250798	Tandem Diabetes Care, Inc.	Control-IQ+ technology
2025-02-24	K243823	Tandem Diabetes Care, Inc.	Control-IQ+ technology
2024-08-26	K241777	Insulet Corporation	SmartAdjust Technology
2024-05-29	K232741	Insulet Corporation	SmartAdjust(TM) technology
2024-05-23	K232603	Camdiab , Ltd.	CamAPS FX
2024-03-13	K234055	Deka Research and Development	DEKA Loop
2023-11-03	K232382	Tandem Diabetes Care, Inc.	Control-IQ Technology
2023-09-22	K232224	Beta Bionics, Inc.	iLet® Dosing Decision Software
2023-05-19	K220916	Beta Bionics, Inc.	iLet® Dosing Decision Software
2023-01-23	K203689	Tidepool Project	Tidepool Loop
2022-08-19	K220394	Insulet Corporation	SmartAdjust(TM) technology
2022-01-27	K203774	Insulet Corporation	SmartAdjust technology
2020-06-16	K200467	Tandem Diabetes Care, Inc.	Control-IQ Technology

QJI · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances