Cleared Traditional

K890904 - MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP (FDA 510(k) Clearance)

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

K890904 · Shiley, Inc. · Cardiovascular device
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Apr 1989
Decision
61d
Days
Class 2
Risk

K890904 is an FDA 510(k) clearance for the MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP. Classified as Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on April 12, 1989 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4370 - 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 K890904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1989
Decision Date April 12, 1989
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4370
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.