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Peritoneal Dialysis Cycler Set (8unit)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K812772

by Dravon Medical, Inc.

Identifiers

510(k) Number
K812772 FDA 510(k)
FDA Product Code
KDJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5630 FDA 510(k)
Regulation Number
876.5630 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Peritoneal Dialysis Cycler Set is a Disposable Administration Set for Peritoneal Dialysis, classified as a Class II medical device. It functions as part of an automated peritoneal dialysis system, facilitating the exchange of dialysate within the peritoneal cavity to remove waste and excess fluids from patients with renal failure or toxemic conditions.

This set is intended for single-use and is supplied sterile, requiring no reprocessing. It is designed for use in clinical settings, including home-based automated peritoneal dialysis (APD) therapy. The device adheres to FDA 510(k) clearance under K812772, with regulatory compliance under 876.5630 for peritoneal dialysis administration sets. Multiple FEI numbers (e.g., 3038277270) identify specific components within the set.

Frequently asked questions

What is the Peritoneal Dialysis Cycler Set (8UNIT) used for?

The Peritoneal Dialysis Cycler Set (8UNIT) is a disposable administration set designed to facilitate the exchange of dialysate within the peritoneal cavity as part of an automated peritoneal dialysis system. It helps remove waste and excess fluids from patients with renal failure or toxemic conditions by connecting to a cycler machine during therapy.

Is the Peritoneal Dialysis Cycler Set (8UNIT) sterile and intended for single use?

Yes, the Peritoneal Dialysis Cycler Set (8UNIT) is supplied sterile and is explicitly designed for single-use only. It requires no reprocessing, cleaning, or resterilization between uses, ensuring patient safety and reducing infection risk in both clinical and home-based automated peritoneal dialysis settings.

How is the Peritoneal Dialysis Cycler Set (8UNIT) supplied and packaged?

The Peritoneal Dialysis Cycler Set (8UNIT) is supplied as a sterile, disposable administration set in a single unit per package. It is intended for immediate use upon opening and does not require any additional preparation, sterilization, or assembly before clinical or home use in automated peritoneal dialysis therapy.

What regulatory pathway was used for the Peritoneal Dialysis Cycler Set (8UNIT)?

The Peritoneal Dialysis Cycler Set (8UNIT) received market authorization through the FDA 510(k) pathway, specifically under submission K812772. It was determined to be substantially equivalent to a predicate device and is classified as a Class II medical device under regulation 876.5630 for peritoneal dialysis administration sets.

What are the FEI numbers associated with the Peritoneal Dialysis Cycler Set (8UNIT)?

The Peritoneal Dialysis Cycler Set (8UNIT) includes multiple Facility Establishment Identifier (FEI) numbers that identify specific components within the set. These include: 3038277270, 3001239013, 3032828299, 3013188547, 3038195011, 1000219637, 2314912, 3002807111, 3002681132, 6898, 3003504604, 3002807005, 3035708507, 3002907620, 3016096143, 3001236277, 1019003, 3004111573, 3015335038, 3039353681, 3002807744, 1000203464, 3002806471, 3001451489, and others listed in the openfda field.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PERITONEAL DIALYSIS CYCLER SET (8UNIT) - Innolitics, Tour of Automated Peritoneal Dialysis (APD) Machines - DaVita, Medical Tube Clamps & Custom IV Bags | Dravon Medical, The Complete Guide to Peritoneal Dialysis Cyclers

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dravon Medical, Inc.

Sources (1)

  • FDA 510(k) K812772 24 fields · synced Sep 19, 2026