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REDY 2000

by Organon Teknika Corp.

510(k) K882428

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882428 Date25 Oct 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FKT
Device Class
Class II
Regulation
21 CFR Part 876.5600
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The REDY 2000 is a System, Dialysate Delivery, Sorbent Regenerated medical device classified under device class 2. It is indicated for use in the medical specialties of Gastroenterology and Urology, as defined by its device type and nomenclature authority.

The device received FDA 510(k) clearance under K882428 on October 25, 1988, following a traditional review process. It was submitted by Organon Teknika Corp. and is associated with product code FKT and regulation number 876.5600. The device is intended for use in clinical settings where dialysate delivery and sorbent regeneration are required, consistent with its classification and authorized indications.

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