Chrysalis Intelligence · Product Codes · OPP

OPP · Unclassified

3 clearances · 1 unique sponsors

Device class
Regulation —
Total clearances
3
2024-01-18 → 2026-04-10
Last 12 months
1
Unique sponsors
1
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
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.

CodeTypeDescriptionConfidenceRationale
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

DateK-numberSponsorDevice
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