Cleared Traditional

K031413 - VIGORMIST COMPRESSOR NEBULIZER

K031413 is an FDA 510(k) clearance for VIGORMIST COMPRESSOR NEBULIZER, manufactured by Vega Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K031413 · Vega Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
155d
Days
Class 2
Risk

K031413 is an FDA 510(k) clearance for the VIGORMIST COMPRESSOR NEBULIZER. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Vega Technologies, Inc. (Taipei, TW). The FDA issued a Cleared decision on October 7, 2003 after a review of 155 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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.

FDA 510(k) Submission Details - K031413

510(k) Number K031413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date October 07, 2003
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 140d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 Consultant

Center For Measurement Standards of Industrial
TZU-WEI LI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTI Compressor, Air, Portable

All 45
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K031413.
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