Cleared Traditional

HEMOPERFUSION PROCEDURE W/REDY 2000 (K842513) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842513 · Organon Teknika Corp. · Gastroenterology & Urology device
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Sep 1984
Decision
78d
Days
Class 2
Risk

K842513 is an FDA 510(k) clearance for the HEMOPERFUSION PROCEDURE W/REDY 2000. Classified as System, Dialysate Delivery, Sorbent Regenerated (product code FKT), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1984 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Organon Teknika Corp. devices

Submission Details

510(k) Number K842513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date September 12, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (FKT) and FDA review panel - the closest regulatory comparables to K842513.
REDY 2000
K882428 · Organon Teknika Corp. · Oct 1988
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
K851188 · Organon Teknika Corp. · Apr 1985
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
K1 POTASSIUM ACETATE ADDITIVE
K801385 · Organon Teknika Corp. · Jul 1980