Cleared Traditional

K133057 - VIBRALUNG ACOUSTICAL PERCUSSOR

K133057 is an FDA 510(k) clearance for VIBRALUNG ACOUSTICAL PERCUSSOR, manufactured by Westmed, Inc.. The device is a Class 2 Anesthesiology device with product code SDT cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K133057 · Westmed, Inc. · Anesthesiology device
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May 2014
Decision
238d
Days
Class 2
Risk

K133057 is an FDA 510(k) clearance for the VIBRALUNG ACOUSTICAL PERCUSSOR. Classified as Intra-pulmonary Percussive Vibration (ipv) Devices (product code SDT), Class II - Special Controls.

Submitted by Westmed, Inc. (Tucson, US). The FDA issued a Cleared decision on May 23, 2014 after a review of 238 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - 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 Westmed, Inc. devices

FDA 510(k) Submission Details - K133057

510(k) Number K133057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2013
Decision Date May 23, 2014
Days to Decision 238 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
98d slower than avg
Panel avg: 140d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SDT Device Classification - Class 2, Special Controls

Product Code SDT Intra-pulmonary Percussive Vibration (ipv) Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
Definition It Is Intended To Mobilize Mucus Using Vibration And/or Pressure Delivered Through A Mouthpiece Into The Airways.
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.