Cleared Traditional

K902298 - ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K902298 · Rondex Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
92d
Days
Class 1
Risk

K902298 is an FDA 510(k) clearance for the ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Rondex Products, Inc. (Rockford, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - 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 Rondex Products, Inc. devices

Submission Details

510(k) Number K902298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1990
Decision Date August 22, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 139d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
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.