Cleared Traditional

K850979 - HEMOCONCENTRATOR KIT

K850979 is the FDA 510(k) clearance for HEMOCONCENTRATOR KIT by Omnis Surgical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K850979 · Omnis Surgical, Inc. · Gastroenterology & Urology device
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Jul 1985
Decision
143d
Days
Class 2
Risk

K850979 is an FDA 510(k) clearance for the HEMOCONCENTRATOR KIT. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Omnis Surgical, Inc. (Deerfield, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Omnis Surgical, Inc. devices

Submission Details

510(k) Number K850979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1985
Decision Date July 29, 1985
Days to Decision 143 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 130d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 96
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K850979.
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
K854309 · Gambro, Inc. · Dec 1985
HOLLOW FIBER DIALYZER
K854586 · Travenol Laboratories, S.A. · Dec 1985
DIMENSION TOTAL HIP PROSTHESIS
K853333 · Kirschner Medical Corp. · Sep 1985
CENTRY 2000 DIALYSIS CONTROL UNIT
K840680 · Cobe Laboratories, Inc. · Apr 1984
BLOOD CONCENTRATOR 140
K840543 · Gambro, Inc. · Mar 1984
HEMOFILTRATION SYSTEM
K831784 · Gambro, Inc. · Feb 1984