Cleared Traditional

K823068 - MEDISYSTEMS FISTULA NEEDLES

K823068 is the FDA 510(k) clearance for MEDISYSTEMS FISTULA NEEDLES by Medisystems Corp.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K823068 · Medisystems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1983
Decision
99d
Days
Class 2
Risk

K823068 is an FDA 510(k) clearance for the MEDISYSTEMS FISTULA NEEDLES. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Medisystems Corp. (Walker, US). The FDA issued a Cleared decision on January 26, 1983 after a review of 99 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

Submission Details

510(k) Number K823068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1982
Decision Date January 26, 1983
Days to Decision 99 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
31d faster than avg
Panel avg: 130d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K823068.
KF-101-07 DIALYZER
K822337 · Extracorporeal Medical Specialities, Inc. · Feb 1983
KF-101-10 DIALYZER
K822338 · Extracorporeal Medical Specialities, Inc. · Feb 1983
KF-101-13 DIALYZER
K822339 · Extracorporeal Medical Specialities, Inc. · Feb 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