Chrysalis Intelligence · Product Codes · OPP

OPP · Pump, Infusion, Insulin Bolus

General Hospital · 3 clearances · 1 unique sponsors

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Device class

Class II

Regulation 880.5725

Total clearances

2024-01-18 → 2026-04-10

Last 12 months

Unique sponsors

Definition

What is Pump, Infusion, Insulin Bolus

The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.

Classification details

Medical specialty

General Hospital

Review panel

Regulation number

880.5725

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
Cequr SA	3	1	2026-04-10

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
E0607	HCPCS	Home blood glucose monitor ✓ CMS-verified description	High	Home blood glucose monitor with integrated voice synthesizer
E0694	HCPCS	Ultraviolet multidirectional light therapy system in 6 foot cabinet, includes bulbs/lamps, timer and eye protection ✓ CMS-verified description	High	Infusion pump, single (including supplies)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-10	K252757	Cequr SA	CeQur Simplicity On-Demand Insulin Delivery System
2024-11-13	K243273	Cequr SA	CeQur Simplicity On-Demand Insulin Delivery System
2024-01-18	K233447	Cequr SA	CeQur Simplicity On-Demand Insulin Delivery System