Cleared Special

K030233 - TRAVELSOME STANDARD

K030233 is an FDA 510(k) clearance for TRAVELSOME STANDARD, manufactured by Sim Italia S.R.L.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Special 510(k) pathway after a 92-day FDA review.

K030233 · Sim Italia S.R.L. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
92d
Days
Class 2
Risk

K030233 is an FDA 510(k) clearance for the TRAVELSOME STANDARD. 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 April 25, 2003 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 868.5440 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030233

510(k) Number K030233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2003
Decision Date April 25, 2003
Days to Decision 92 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 140d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

CAW Device Classification - Class 2, Special Controls

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 234
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K030233.
MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905
K040892 · Nidek Medical Products, Inc. · Apr 2004
MARK 5 NUVO (M5C5)
K032509 · Nidek Medical Products, Inc. · Mar 2004
POGS 33
K030920 · On Site Gas Systems, Inc. · Mar 2004
PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
K022684 · Essex Cryogenics of Missouri, Inc. · Sep 2002
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K021685 · Invacare Corp. · Jul 2002
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
K020386 · Invacare Corp. · Jul 2002
K030233 · TRAVELSOME STANDARD
Download PDF FDA Summary Sim Italia S.R.L.