Cleared Traditional

SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR (K894630) - FDA 510(k) Clearance

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

K894630 · Shiley, Inc. · Cardiovascular device
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Oct 1989
Decision
88d
Days
Class 2
Risk

K894630 is an FDA 510(k) clearance for the SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on October 20, 1989 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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: 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 K894630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date October 20, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 91
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K894630.
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461
K896671 · 3M Company · Feb 1990
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
K895632 · 3M Company · Dec 1989
SARNS INGANT MEMBRANE OXYGENATOR
K895393 · 3M Company · Dec 1989
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV
K890808 · 3M Company · May 1989
BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600
K864235 · C.R. Bard, Inc. · Jan 1987
CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
K861177 · Terumo Medical Corp. · May 1986