Cleared Traditional

PERMCATH INSERTION TRAY (K874633) - FDA 510(k) Clearance

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

K874633 · Quinton, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
100d
Days
Class 2
Risk

K874633 is an FDA 510(k) clearance for the PERMCATH INSERTION TRAY. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on February 17, 1988 after a review of 100 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 Quinton, Inc. devices

Submission Details

510(k) Number K874633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received November 09, 1987
Decision Date February 17, 1988
Days to Decision 100 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
30d faster than avg
Panel avg: 130d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K874633.
MODIFIED PERM-CATH
K900835 · Quinton, Inc. · May 1990
SUBCLAVIAN HEMODIALYSIS CATHETER
K884322 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1989
MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA
K881290 · Shiley, Inc. · Apr 1988
ADULT PERM-CATH 40CM.
K871749 · Quinton, Inc. · Jun 1987
PERM-CATH CATHETER KIT
K871942 · Quinton, Inc. · Jun 1987
SINGLE LUMEN ACUTE CATHETER
K870328 · Quinton, Inc. · May 1987