FKX · System, Peritoneal, Automatic Delivery

Device class

Class II

Regulation 876.5630

Total clearances

2020-11-19 → 2025-10-02

Last 12 months

Unique sponsors

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.5630

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
Fresenius Medical Care Renal Therapies Group, LLC	2	0	2022-10-31
Baxter Healthcare Corporation	1	0	2020-11-19
Cloudcath	1	0	2022-02-09
Simergent, LLC	1	1	2025-10-02
Iren-Medical, Ltd.	1	0	2022-12-29
Byonyks Pvt, Ltd.	1	0	2025-05-16

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
E1592	HCPCS	Automatic intermittent peritoneal dialysis system ✓ CMS-verified description	High	Automatic peritoneal dialysis (APD) system

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-10-02	K250523	Simergent, LLC	Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
2025-05-16	K243371	Byonyks Pvt, Ltd.	Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
2022-12-29	K220935	Iren-Medical, Ltd.	Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
2022-10-31	K222318	Fresenius Medical Care Renal Therapies Group, LLC	Fresenius Liberty Select Cycler
2022-04-15	K212522	Fresenius Medical Care Renal Therapies Group, LLC	Lilliput APD System
2022-02-09	K212658	Cloudcath	CloudCath Peritoneal Dialysis Drain Set Monitoring System
2020-11-19	K201867	Baxter Healthcare Corporation	Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System