Cleared Traditional

K913527 - HYPERFREE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K913527 · Kist Intl. · Anesthesiology device
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Jan 1992
Decision
166d
Days
Class 1
Risk

K913527 is an FDA 510(k) clearance for the HYPERFREE. Classified as Bottle, Blow (product code BYO), Class I - General Controls.

Submitted by Kist Intl. (Lewiston, US). The FDA issued a Cleared decision on January 21, 1992 after a review of 166 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5220 - 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 Kist Intl. devices

Submission Details

510(k) Number K913527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1991
Decision Date January 21, 1992
Days to Decision 166 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 139d · This submission: 166d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYO Bottle, Blow
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5220
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.