Cleared Traditional

K920594 - SHILEY PERFUSION TUBING SETS

K920594 is an FDA 510(k) clearance for SHILEY PERFUSION TUBING SETS, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 401-day FDA review.

K920594 · Shiley, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
401d
Days
Class 2
Risk

K920594 is an FDA 510(k) clearance for the SHILEY PERFUSION TUBING SETS. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on March 18, 1993 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Shiley, Inc. devices

FDA 510(k) Submission Details - K920594

510(k) Number K920594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date March 18, 1993
Days to Decision 401 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
276d slower than avg
Panel avg: 125d · This submission: 401d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTM Device Classification - Class 2, Special Controls

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 73
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K920594.
CAPIOX ARTERIAL FILTER
K943917 · Terumo Medical Corp. · Jul 1995
MEDTRONIC ARTERIAL FILTER
K926413 · Medtronic Vascular · Aug 1993
GISH ARTERIAL FILTER
K914791 · Gish Biomedical, Inc. · Apr 1993
MODIFIED PYROGEN TESTING
K910935 · Electromedics, Inc. · May 1991
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
K902723 · Electromedics, Inc. · Dec 1990
LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
K902518 · Pall Biomedical Products Co. · Oct 1990