Cleared Traditional

SORB II (K813574) - FDA 510(k) Clearance

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

K813574 · Organon Teknika Corp. · Gastroenterology & Urology device
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Mar 1982
Decision
90d
Days
Class 2
Risk

K813574 is an FDA 510(k) clearance for the SORB II. 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 March 23, 1982 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K813574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1981
Decision Date March 23, 1982
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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 K813574.
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
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