Cleared Traditional

K163091 - VibraPEP

K163091 is an FDA 510(k) clearance for VibraPEP, manufactured by Medica Holdings, LLC. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K163091 · Medica Holdings, LLC · Anesthesiology device
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Feb 2017
Decision
109d
Days
Class 2
Risk

K163091 is an FDA 510(k) clearance for the VibraPEP. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Medica Holdings, LLC (Lake Oswego, US). The FDA issued a Cleared decision on February 21, 2017 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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 Medica Holdings, LLC devices

FDA 510(k) Submission Details - K163091

510(k) Number K163091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2016
Decision Date February 21, 2017
Days to Decision 109 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
31d faster than avg
Panel avg: 140d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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 - BWF Spirometer, Therapeutic (incentive)

All 37
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K163091.
Combined Aerobika OPEP and VersaPAP device
K183108 · Trudell Medical International · Aug 2019
Hudson RCI Voldyne Volumetric Exerciser
K182847 · Teleflexmedical, Inc. · Jul 2019
VersaPAP Positive Airway Pressure (PAP) Device
K173918 · Trudell Medical International · Aug 2018
VITAL PEP
K984468 · Vital Signs, Inc. · Jun 1999
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138 · Monaghan Medical Corp. · Mar 1991
AMBU RMT VALVE
K873579 · Ambu, Inc. · Dec 1987