Cleared Traditional

K813432 - HEMODIALYSIS SYSTEM

K813432 is the FDA 510(k) clearance for HEMODIALYSIS SYSTEM by Fhk. It is a Class 2 Gastroenterology & Urology device (product code FKP) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K813432 · Fhk · Gastroenterology & Urology device
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Jun 1982
Decision
197d
Days
Class 2
Risk

K813432 is an FDA 510(k) clearance for the HEMODIALYSIS SYSTEM. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Fhk (Mchenry, US). The FDA issued a Cleared decision on June 23, 1982 after a review of 197 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Fhk devices

Submission Details

510(k) Number K813432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1981
Decision Date June 23, 1982
Days to Decision 197 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
67d slower than avg
Panel avg: 130d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKP System, Dialysate Delivery, Single Patient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FKP System, Dialysate Delivery, Single Patient

All 37
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K813432.
COBE SYSTEM 3
K851306 · Cobe Laboratories, Inc. · Jun 1985
BSM 2000 DIALYSIS MACHINE - MODIFIED
K850569 · Organon Teknika Corp. · Mar 1985
MBM(TM) MONITRAL (R) BICARBONATE MODULE
K850179 · Hospal Medical Corp. · Feb 1985
EXTRASENSR ULTRAFILTRATION MONITOR
K811972 · Extracorporeal Medical Specialities, Inc. · Nov 1981
B-D DRAKE WILLOCK #7000 SERIES ULTRAF
K811591 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1981
EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS
K802880 · Extracorporeal Medical Specialities, Inc. · Dec 1980