Cleared Traditional

INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (K963042) - FDA 510(k) Clearance

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

K963042 · Sim Italia S.R.L. · Anesthesiology device
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Nov 1996
Decision
88d
Days
Class 2
Risk

K963042 is an FDA 510(k) clearance for the INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Sim Italia S.R.L. (Great Neck,, US). The FDA issued a Cleared decision on November 1, 1996 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sim Italia S.R.L. devices

Submission Details

510(k) Number K963042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1996
Decision Date November 01, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 67
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