Cleared Traditional

K963755 - SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR

K963755 is an FDA 510(k) clearance for SPIRACLE TECHNOLOGY - MODEL 302 OX INHA..., manufactured by Spiracle Technology. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K963755 · Spiracle Technology · Anesthesiology device
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Apr 1997
Decision
202d
Days
Class 2
Risk

K963755 is an FDA 510(k) clearance for the SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR. 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 April 8, 1997 after a review of 202 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

FDA 510(k) Submission Details - K963755

510(k) Number K963755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1996
Decision Date April 08, 1997
Days to Decision 202 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
62d slower than avg
Panel avg: 140d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CBP Valve, Non-rebreathing

All 45
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K963755.
NON-REBREATHING 'T' (BE 117)
K973066 · Instrumentation Industries, Inc. · Feb 1998
ONE-WAY VALVE (WITH CONNECTOR)
K970780 · Instrumentation Industries, Inc. · Sep 1997
CPROTECTOR 2000
K960587 · Certified Safety Mfg., Inc. · Jul 1997
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955634 · Boston Medical Products, Inc. · Jun 1996
CPR MICROMASK WITH OXYGEN INLET
K953414 · Plasco, Inc. · Mar 1996
CPR MICROMASK
K951483 · Plasco, Inc. · Oct 1995