--- title: "Renal Care Devices, Definition | MedTech Terms" description: "Devices for hemodialysis, peritoneal dialysis, and continuous renal replacement therapy in ESRD and AKI patients." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/renal-care-devices#term", "name": "Renal Care Devices", "alternateName": [ "Hemodialysis devices", "Dialysis" ], "description": "The renal-care segment includes in-center hemodialysis machines, home hemodialysis systems (NxStage), peritoneal dialysis cyclers, continuous renal replacement therapy (CRRT) for ICU AKI, dialyzers, and vascular access devices. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Renal Care Devices [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape) # Renal Care Devices Devices for hemodialysis, peritoneal dialysis, and continuous renal replacement therapy in ESRD and AKI patients. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 9, 2026 ## Definition The renal-care segment includes in-center hemodialysis machines, home hemodialysis systems (NxStage), peritoneal dialysis cyclers, continuous renal replacement therapy (CRRT) for ICU AKI, dialyzers, and vascular access devices. The segment is reimbursement-dominated: ESRD care is one of the few diagnoses with universal Medicare entitlement under the End-Stage Renal Disease Program (1972 Social Security Amendments). What the regulation says Hemodialysis machines are Class II under 21 CFR 876.5820. CMS regulates the dialysis facility itself under 42 CFR 494 (ESRD Conditions for Coverage). The ESRD Prospective Payment System (ESRD PPS) bundles dialysis services under a single per-treatment payment. ## What this means in practice The 2019 'Advancing American Kidney Health' executive order pushed home dialysis adoption and the development of wearable/implantable kidney devices via the KidneyX innovation prize. Common pitfalls - • Designing without regard to the bundled ESRD PPS payment structure. - • Underestimating dialysis-water purity requirements (AAMI/ANSI/ISO 13959). ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Reimbursement Value-Based Care(VBC) Payment tied to outcomes and total cost of care, not volume of services. ](/terms/value-based-care) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 CMS· 1 HHS / ASN· 1 MedTech Europe· 1 1. [1 CMS ESRD Conditions for Coverage Verified CMS · cms.gov ](https://www.cms.gov/regulations-and-guidance/legislation/cfcsandcops/esrd) 2. [2 KidneyX Verified HHS / ASN · kidneyx.org ](https://www.kidneyx.org/) 3. [3 MedTech Europe - Facts & Figures Verified MedTech Europe · medtecheurope.org ](https://www.medtecheurope.org/datahub/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Sources 3 Updated 5/9/2026 [Compare with another term](/compare?a=renal-care-devices) Learn in 60 seconds Card Lesson Quiz Devices for hemodialysis, peritoneal dialysis, and continuous renal replacement therapy in ESRD and AKI patients. - · The 2019 'Advancing American Kidney Health' executive order pushed home dialysis adoption and the development of wearable/implantable kidney devices via the KidneyX innovation prize. - · The segment is reimbursement-dominated: ESRD care is one of the few diagnoses with universal Medicare entitlement under the End-Stage Renal Disease Program (1972 Social Security Amendments). Remember this Watch out: Designing without regard to the bundled ESRD PPS payment structure. Related terms - [Premarket Approval(PMA) ](/terms/pma) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Value-Based Care(VBC) ](/terms/value-based-care) You may also need Auto-suggested from Market Segments and shared keywords. - [Cardiac Rhythm Management(CRM) ](/terms/cardiac-rhythm-management) - [Dental Devices ](/terms/dental-devices) - [Sleep & Respiratory Devices ](/terms/sleep-respiratory-devices) - [Urology Devices ](/terms/urology-devices) - [Wound Care ](/terms/wound-care) - [Diabetes Care ](/terms/diabetes-care) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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