Cleared Traditional

I.V. SKY-HOOK (K912010) - FDA 510(k) Clearance

Class I General Hospital device.

K912010 · Dina - Industria, Comercio E Exportacao , Ltd. · General Hospital
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Aug 1991
Decision
105d
Days
Class 1
Risk

K912010 is an FDA 510(k) clearance for the I.V. SKY-HOOK. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Dina - Industria, Comercio E Exportacao , Ltd. (Miami, US). The FDA issued a Cleared decision on August 19, 1991 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6990 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Dina - Industria, Comercio E Exportacao , Ltd. devices

Submission Details

510(k) Number K912010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1991
Decision Date August 19, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOX Stand, Infusion
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6990
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.