Cleared Traditional

K934782 - AMMEX TUBING ORGANIZER

K934782 is an FDA 510(k) clearance for AMMEX TUBING ORGANIZER, manufactured by Ammex Cardiopulmonary Corp.. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K934782 · Ammex Cardiopulmonary Corp. · Cardiovascular device
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Nov 1993
Decision
43d
Days
Class 1
Risk

K934782 is an FDA 510(k) clearance for the AMMEX TUBING ORGANIZER. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Ammex Cardiopulmonary Corp. (Houston, US). The FDA issued a Cleared decision on November 18, 1993 after a review of 43 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 Ammex Cardiopulmonary Corp. devices

FDA 510(k) Submission Details - K934782

510(k) Number K934782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1993
Decision Date November 18, 1993
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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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