Cleared Traditional

K953349 - SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953349 · Spiracle Technology · Anesthesiology device
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Feb 1996
Decision
227d
Days
Class 2
Risk

K953349 is an FDA 510(k) clearance for the SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Spiracle Technology (Irvine, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 227 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 Spiracle Technology devices

Submission Details

510(k) Number K953349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date February 29, 1996
Days to Decision 227 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
88d slower than avg
Panel avg: 139d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.