Cleared Traditional

K832547 - ULTRAFILTRATION CONTROLLER

K832547 is the FDA 510(k) clearance for ULTRAFILTRATION CONTROLLER by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K832547 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Jan 1984
Decision
155d
Days
Class 2
Risk

K832547 is an FDA 510(k) clearance for the ULTRAFILTRATION CONTROLLER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Walker, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 155 days - an extended review cycle.

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 Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K832547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1983
Decision Date January 03, 1984
Days to Decision 155 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
25d slower than avg
Panel avg: 130d · This submission: 155d
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 95
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K832547.
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
ULTRAFILTRATION MONITOR UFM-10-2
K830596 · Gambro, Inc. · Apr 1983
FH 101, FH 202 & FH 303 FIBER HEMOFILTER
K830284 · Gambro, Inc. · Mar 1983
COBE HEMOCONCENTRATOR 1.3
K823338 · Cobe Laboratories, Inc. · Jan 1983