Cleared Traditional

K881065 - RESUS-AID (FDA 510(k) Clearance)

Class I Anesthesiology device.

K881065 · Applied Convergent Technologies, Inc. · Anesthesiology device
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Jul 1988
Decision
122d
Days
Class 1
Risk

K881065 is an FDA 510(k) clearance for the RESUS-AID. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Applied Convergent Technologies, Inc. (City Of Industry, US). The FDA issued a Cleared decision on July 14, 1988 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - 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 Applied Convergent Technologies, Inc. devices

Submission Details

510(k) Number K881065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1988
Decision Date July 14, 1988
Days to Decision 122 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 139d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
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.