Cleared Traditional

K822964 - RIGHT ATRIAL CATHETER

K822964 is an FDA 510(k) clearance for RIGHT ATRIAL CATHETER, manufactured by Quinton, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K822964 · Quinton, Inc. · Gastroenterology & Urology device
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Nov 1982
Decision
56d
Days
Class 2
Risk

K822964 is an FDA 510(k) clearance for the RIGHT ATRIAL CATHETER. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on November 30, 1982 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quinton, Inc. devices

FDA 510(k) Submission Details - K822964

510(k) Number K822964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1982
Decision Date November 30, 1982
Days to Decision 56 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
75d faster than avg
Panel avg: 131d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFJ Device Classification - Class 2, Special Controls

Product Code LFJ Catheter, Subclavian
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - LFJ Catheter, Subclavian

All 63
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K822964.
DUAL LUMEN SUBCLAVIAN CANNULA
K833848 · Shiley, Inc. · Dec 1983
MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM
K830438 · Medcomp · Mar 1983
DOUBLE LUMEN SUBCLAVIAN CATHETER
K823135 · Abbott Laboratories · Mar 1983
RIGHT ARTERIAL CATHETER
K822910 · Quinton, Inc. · Nov 1982
SHIELY DUEL LUMEN SUBCLAVIAN CANNULA
K822134 · Shiley, Inc. · Aug 1982
MCPARLAND SCALP VEIN CATHETER
K821001 · Renal Systems, Inc. · Jul 1982