Chrysalis Intelligence · Product Codes · FJK

FJK · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Gastroenterology, Urology · 8 clearances · 7 unique sponsors

Device class
Class II
Regulation 876.5820
Total clearances
8
2021-03-10 → 2026-05-15
Last 12 months
3
Unique sponsors
7
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
Bain Medical Equipment (Guangzhou) Co., Ltd. 2 1 2026-05-15
Diality, Inc. 1 0 2024-12-20
Vital Healthcare Sdn. Bhd. 1 1 2026-01-16
Ningbo Tianyi Medical Appliance Co., Ltd. 1 1 2025-10-02
Fresenius Medical Care Renal Therapies Group, LLC 1 0 2023-05-31
Jiangxi Sanxin Medtec Co., Ltd. 1 0 2021-09-06
Outset Medical, Inc. 1 0 2021-11-26
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
E1600 HCPCS Delivery and/or installation charges for hemodialysis equipment ✓ CMS-verified description Medium Dialysis blood tubing set and related supplies
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-15 K252423 Bain Medical Equipment (Guangzhou) Co., Ltd. NovaLine Tubing Set for Hemodialysis (BL 124)
2026-01-16 K251341 Vital Healthcare Sdn. Bhd. VITAL Tubing Sets for Hemodialysis
2025-10-02 K251442 Ningbo Tianyi Medical Appliance Co., Ltd. TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
2024-12-20 K243607 Diality, Inc. Moda-flx Hemodialysis System™ Cartridge (102121-001 )
2023-05-31 K213992 Fresenius Medical Care Renal Therapies Group, LLC CombiSet Hemodialysis Blood Tubing Set
2021-11-26 K210782 Outset Medical, Inc. Tablo Cartridge
2021-09-06 K202796 Jiangxi Sanxin Medtec Co., Ltd. SANSIN Tubing Sets for Hemodialysis
2021-03-10 K201866 Bain Medical Equipment (Guangzhou) Co., Ltd. NovaLine Tubing Sets for Hemodialysis