Chrysalis Intelligence · Product Codes · PKP

PKP · Unclassified

4 clearances · 1 unique sponsors

Device class
Regulation —
Total clearances
4
2022-10-13 → 2025-12-22
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
Emed Technologies Corporation 4 1 2025-12-22
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
96365 CPT High Intravenous infusion for subcutaneous IgG delivery setup and administration
96367 CPT Medium Subcutaneous infusion of biological agent (IgG) with extended infusion time
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-12-22 K251105 Emed Technologies Corporation Tetra (TM-20); Tetra (TM-50)
2024-02-16 K240148 Emed Technologies Corporation SCIg60 Infusion System
2023-11-28 K230883 Emed Technologies Corporation VersaPump Infusion System
2022-10-13 K222087 Emed Technologies Corporation SCIg60 Infusion System