Cleared Traditional

K922404 - TUBE GRIP

K922404 is an FDA 510(k) clearance for TUBE GRIP, manufactured by Georgia Medical Products, Inc.. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 186-day FDA review.

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

FDA 510(k) Submission Details - K922404

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.

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 33
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