Cleared Traditional

K821001 - MCPARLAND SCALP VEIN CATHETER

K821001 is an FDA 510(k) clearance for MCPARLAND SCALP VEIN CATHETER, manufactured by Renal Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K821001 · Renal Systems, Inc. · Gastroenterology & Urology device
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Jul 1982
Decision
105d
Days
Class 2
Risk

K821001 is an FDA 510(k) clearance for the MCPARLAND SCALP VEIN CATHETER. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Renal Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 105 days - within the typical 510(k) review window.

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: 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 Renal Systems, Inc. devices

FDA 510(k) Submission Details - K821001

510(k) Number K821001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1982
Decision Date July 22, 1982
Days to Decision 105 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
26d faster than avg
Panel avg: 131d · This submission: 105d
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 K821001.
RIGHT ATRIAL CATHETER
K822964 · Quinton, Inc. · Nov 1982
RIGHT ARTERIAL CATHETER
K822910 · Quinton, Inc. · Nov 1982
SHIELY DUEL LUMEN SUBCLAVIAN CANNULA
K822134 · Shiley, Inc. · Aug 1982
MCSCK838 CATHETER IN A TRAY (KIT)
K821954 · Medcomp · Jul 1982
MCSCK638 CATHETER IN A TRAY (KIT)
K821955 · Medcomp · Jul 1982
MCSCP8PS WITH 'Y' HUB
K821684 · Medical Components, Inc. · Jun 1982