Cleared Traditional

K960240 - RUSCH OPTOSAFE

K960240 is the FDA 510(k) clearance for RUSCH OPTOSAFE by Rusch Intl.. It is a Class 1 Anesthesiology device (product code CAE) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K960240 · Rusch Intl. · Anesthesiology device
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Apr 1996
Decision
94d
Days
Class 1
Risk

K960240 is an FDA 510(k) clearance for the RUSCH OPTOSAFE. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on April 19, 1996 after a review of 94 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 Rusch Intl. devices

Submission Details

510(k) Number K960240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date April 19, 1996
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 140d · This submission: 94d
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.

Regulatory Peers - CAE Airway, Oropharyngeal, Anesthesiology

All 9
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K960240.
CUFFED OROPHARYNGEAL AIRWAY (COPA)
K955721 · Mallinckrodt Medical · Mar 1997
GUEDEL AIRWAY
K953400 · Mallinckrodt Medical · Oct 1995
CURITY FIBEROPTIC INTUBATING AIRWAY
K855137 · The Kendal Co. · Mar 1986
RESPIRONICS VENT EASY OXYGEN ENRICHME
K842605 · Respironics, Inc. · Jul 1984
RESPIRONICS RESCUE DOME
K833328 · Respironics, Inc. · Dec 1983
7CM BERMAN AIRWAY
K820512 · Vital Signs, Inc. · Mar 1982