Cleared Traditional

K864890 - STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP

K864890 is an FDA 510(k) clearance for STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP, manufactured by Shiley, Inc.. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K864890 · Shiley, Inc. · Cardiovascular device
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Feb 1987
Decision
66d
Days
Class 1
Risk

K864890 is an FDA 510(k) clearance for the STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on February 19, 1987 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4200 - 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

FDA 510(k) Submission Details - K864890

510(k) Number K864890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1986
Decision Date February 19, 1987
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

KRI Device Classification - Class 1, General Controls

Product Code KRI Accessory Equipment, Cardiopulmonary Bypass
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KRI Accessory Equipment, Cardiopulmonary Bypass

All 26
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K864890.
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K854113 · American Bentley · Jan 1986
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
K852455 · Gambro, Inc. · Sep 1985