Cleared Traditional

K921510 - GAS SAMPLING KIT MODIFICATION (FDA 510(k) Clearance)

Class I Anesthesiology device.

K921510 · Respiratory Support Products, Inc. · Anesthesiology device
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Jun 1992
Decision
90d
Days
Class 1
Risk

K921510 is an FDA 510(k) clearance for the GAS SAMPLING KIT MODIFICATION. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Respiratory Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on June 11, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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 Respiratory Support Products, Inc. devices

Submission Details

510(k) Number K921510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date June 11, 1992
Days to Decision 90 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
49d faster than avg
Panel avg: 139d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
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.