Cleared Traditional

DUAL LUMEN NEEDLE (K833308) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833308 · Quinton, Inc. · Gastroenterology & Urology device
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Dec 1983
Decision
92d
Days
Class 2
Risk

K833308 is an FDA 510(k) clearance for the DUAL LUMEN NEEDLE. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Quinton, Inc. (Walker, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 92 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 Quinton, Inc. devices

Submission Details

510(k) Number K833308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1983
Decision Date December 27, 1983
Days to Decision 92 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
38d faster than avg
Panel avg: 130d · This submission: 92d
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 26
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K833308.
HOLLOW FIBER DIALYZER
K843632 · Travenol Laboratories, S.A. · Oct 1984
CAPILLARY FLOW DIALYZERS
K840937 · Travenol Laboratories, S.A. · Sep 1984
HOLLOW FIBER DIALYZERS
K840845 · Travenol Laboratories, S.A. · Aug 1984
C-DAK ARTIFICIAL KIDNEY
K830729 · Cordis Corp. · Mar 1983
A.V. FISTULA CANNULATION SETS
K830021 · Travenol Laboratories, S.A. · Jan 1983
CAPILLARY FLOW DIALYZERS
K823826 · Travenol Laboratories, S.A. · Jan 1983