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ROPE System Reverse Osmosis Peritoneal System

by Organon Teknika Corp. 510(k)

Active United States

510(k) K844630

Overview

The ROPE System Reverse Osmosis Peritoneal System is an automatic delivery system designed for peritoneal use, classified under gastroenterology and urology medical specialties. It functions as a reverse osmosis system for peritoneal applications, facilitating automated fluid processing and delivery.

This device was manufactured by Organon Teknika Corp. and received FDA 510(k) clearance under K844630, classified as substantially equivalent. It is regulated under product code FKX and regulation number 876.5630, with a decision date of March 12, 1985. The system is intended for use in clinical settings requiring automated peritoneal delivery and reverse osmosis processing.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844630 Date12 Mar 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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