Cleared Traditional

K954623 - REDY 2000 SYSTEM (THERAPEUTIC PLASMA EX...

K954623 is an FDA 510(k) clearance for REDY 2000 SYSTEM (THERAPEUTIC PLASMA EX..., manufactured by Gambro Healthcare. The device is a Class 2 Gastroenterology & Urology device with product code FKT cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K954623 · Gambro Healthcare · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
328d
Days
Class 2
Risk

K954623 is an FDA 510(k) clearance for the REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CO.... Classified as System, Dialysate Delivery, Sorbent Regenerated (product code FKT), Class II - Special Controls.

Submitted by Gambro Healthcare (Oklahoma City, US). The FDA issued a Cleared decision on August 28, 1996 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5600 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gambro Healthcare devices

FDA 510(k) Submission Details - K954623

510(k) Number K954623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1995
Decision Date August 28, 1996
Days to Decision 328 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 130d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKT Device Classification - Class 2, Special Controls

Product Code FKT System, Dialysate Delivery, Sorbent Regenerated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FKT System, Dialysate Delivery, Sorbent Regenerated

All 9
Devices cleared under the same product code (FKT) and FDA review panel - the closest regulatory comparables to K954623.
REDY 2000
K882428 · Organon Teknika Corp. · Oct 1988
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
K851188 · Organon Teknika Corp. · Apr 1985
HEMOPERFUSION PROCEDURE W/REDY 2000
K842513 · Organon Teknika Corp. · Sep 1984
SORB II
K813574 · Organon Teknika Corp. · Mar 1982
D-3260 SORBENT CARTRIDGE
K812869 · Organon Teknika Corp. · Dec 1981
D-3160 SORBENT CARTRIDGE
K811170 · Organon Teknika Corp. · Jul 1981