Cleared Traditional

K896608 - SPAG PAK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K896608 · Viratek, Inc. · Anesthesiology device
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Apr 1990
Decision
139d
Days
Class 1
Risk

K896608 is an FDA 510(k) clearance for the SPAG PAK. Classified as Tent, Oxygen (product code BYL), Class I - General Controls.

Submitted by Viratek, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on April 9, 1990 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5700 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Viratek, Inc. devices

Submission Details

510(k) Number K896608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date April 09, 1990
Days to Decision 139 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 139d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYL Tent, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5700
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.