Skip to content

Acute Peritoneal Dialysis Kit

by Quinton, Inc. 510(k)

Active United States

510(k) K870472

Overview

The Acute Peritoneal Dialysis Kit is a device used as an artificial kidney system for peritoneal dialysis. It is classified as a catheter for peritoneal dialysis, designed for single use. The kit includes components necessary for performing acute peritoneal dialysis procedures.

The device is supplied as a single-use kit and is regulated under FDA 510(k) clearance with product code FKO. It is classified as Class II with special controls. The kit is manufactured by Quinton, Inc. and is intended for use in gastroenterology and urology settings. No specific MRI safety information is provided in the data.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870472 Date25 Feb 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FKO
Device Class
Class II
Regulation
21 CFR Part 876.5630
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Quinton, Inc.

See all devices from Quinton, Inc. →

Questions

  • What is the Acute Peritoneal Dialysis Kit used for?

    The Acute Peritoneal Dialysis Kit is used as an artificial kidney system for peritoneal dialysis procedures. It is designed for single use and includes all components necessary to perform acute peritoneal dialysis in gastroenterology and urology settings.

  • Is the Acute Peritoneal Dialysis Kit supplied as a single-use device?

    Yes, the Acute Peritoneal Dialysis Kit is supplied as a single-use kit. It is classified as a catheter for peritoneal dialysis and is designed to be used only once before being discarded.

  • What regulatory classification does the Acute Peritoneal Dialysis Kit have?

    The Acute Peritoneal Dialysis Kit is regulated under FDA 510(k) clearance with product code FKO. It is classified as Class II with special controls, indicating it has moderate risk and requires specific controls to ensure safety and effectiveness.

  • What components are included in the Acute Peritoneal Dialysis Kit?

    The Acute Peritoneal Dialysis Kit includes all components necessary for performing acute peritoneal dialysis procedures. While specific components aren't detailed in the provided information, the kit is designed to provide everything needed for the artificial kidney system in clinical settings.