Cleared Traditional

TUBE GRIP (K922404) - FDA 510(k) Clearance

Class I Cardiovascular device.

K922404 · Georgia Medical Products, Inc. · Cardiovascular device
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Nov 1992
Decision
186d
Days
Class 1
Risk

K922404 is an FDA 510(k) clearance for the TUBE GRIP. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Georgia Medical Products, Inc. (Marietta, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 186 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Georgia Medical Products, Inc. devices

Submission Details

510(k) Number K922404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1992
Decision Date November 23, 1992
Days to Decision 186 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K922404.
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