Cleared Traditional

K791829 - SHILEY QUICK DISCONNECT ASSEMBLY

K791829 is an FDA 510(k) clearance for SHILEY QUICK DISCONNECT ASSEMBLY, 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 15-day FDA review.

K791829 · Shiley, Inc. · Cardiovascular device
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Oct 1979
Decision
15d
Days
Class 1
Risk

K791829 is an FDA 510(k) clearance for the SHILEY QUICK DISCONNECT ASSEMBLY. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1979 after a review of 15 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 - K791829

510(k) Number K791829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1979
Decision Date October 02, 1979
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
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 K791829.
DISPOSABLE PARALLEL Y CONNECTORS
K802541 · Texas Medical Products, Inc. · Jan 1981
DISPOSABLE CONNECTORS
K802542 · Texas Medical Products, Inc. · Jan 1981
WILLIAM HARVEY OXYGENATING GAS FILTER
K802906 · C.R. Bard, Inc. · Dec 1980
FILTER, EXTRACORPOREAL BLOOD HOLDER
K781861 · Surgikos, Inc. · Nov 1978
PVC QUICK PRIME LINES
K780984 · Norton Performance Plastics Corp. · Jul 1978
VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
K770681 · Scimed Life Systems, Inc. · Apr 1977