Cleared Traditional

K823069 - KF-E SERIES HOLLOW FIBER DIALYZER

K823069 is an FDA 510(k) clearance for KF-E SERIES HOLLOW FIBER DIALYZER, manufactured by Medisystems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K823069 · Medisystems Corp. · Gastroenterology & Urology device
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Jan 1983
Decision
94d
Days
Class 2
Risk

K823069 is an FDA 510(k) clearance for the KF-E SERIES HOLLOW FIBER DIALYZER. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Medisystems Corp. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 94 days - within the typical 510(k) review window.

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 Medisystems Corp. devices

FDA 510(k) Submission Details - K823069

510(k) Number K823069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1982
Decision Date January 21, 1983
Days to Decision 94 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
37d faster than avg
Panel avg: 131d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 137
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K823069.
KF-101-10 DIALYZER
K822338 · Extracorporeal Medical Specialities, Inc. · Feb 1983
KF-101-13 DIALYZER
K822339 · Extracorporeal Medical Specialities, Inc. · Feb 1983
MEDISYSTEMS FISTULA NEEDLES
K823068 · Medisystems Corp. · Jan 1983
A.V. FISTULA CANNULATION SETS
K830021 · Travenol Laboratories, S.A. · Jan 1983
LUNDIA 10-5-L PARRALLE FLOW DIALYZER
K823791 · Gambro, Inc. · Jan 1983
CAPILLARY FLOW DIALYZERS
K823826 · Travenol Laboratories, S.A. · Jan 1983