Cleared Traditional

MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA (K881290) - FDA 510(k) Clearance

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

K881290 · Shiley, Inc. · Gastroenterology & Urology device
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Apr 1988
Decision
30d
Days
Class 2
Risk

K881290 is an FDA 510(k) clearance for the MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on April 27, 1988 after a review of 30 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 Shiley, Inc. devices

Submission Details

510(k) Number K881290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date April 27, 1988
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
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 K881290.
ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
K913468 · Cook, Inc. · Mar 1994
MODIFIED PERM-CATH
K900835 · Quinton, Inc. · May 1990
SUBCLAVIAN HEMODIALYSIS CATHETER
K884322 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1989
PERMCATH INSERTION TRAY
K874633 · Quinton, Inc. · Feb 1988
ADULT PERM-CATH 40CM.
K871749 · Quinton, Inc. · Jun 1987
PERM-CATH CATHETER KIT
K871942 · Quinton, Inc. · Jun 1987