Chrysalis Intelligence · Product Codes · KOC

KOC · Accessories, Blood Circuit, Hemodialysis

Gastroenterology, Urology · 5 clearances · 2 unique sponsors

Device class
Class II
Regulation 876.5820
Total clearances
5
2020-09-18 → 2025-05-15
Last 12 months
0
Unique sponsors
2
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5820
Implant
N
Life-sustain / support
Y
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
NIKKISO CO., LTD. 4 0 2025-05-15
Fresenius Medical Care Renal Therapies Group, LLC 1 0 2020-09-18
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
A4674 HCPCS Chemicals/antiseptics solution used to clean/sterilize dialysis equipment, per 8 oz ✓ CMS-verified description High Sterile blood line set for hemodialysis
A4680 HCPCS Activated carbon filter for hemodialysis, each ✓ CMS-verified description Medium Dialysis circuit venous drip chamber with integrated thermostat
A4750 HCPCS Blood tubing, arterial or venous, for hemodialysis, each ✓ CMS-verified description Medium Blood pump tubing, single segment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-05-15 K242479 NIKKISO CO., LTD. BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
2025-05-15 K242176 NIKKISO CO., LTD. BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
2023-07-28 K231589 NIKKISO CO., LTD. Blood Tubing Lines for Hemodialysis AV06C-E
2023-06-16 K230514 NIKKISO CO., LTD. Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
2020-09-18 K201207 Fresenius Medical Care Renal Therapies Group, LLC CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line