Cleared Traditional

K142482 - The Vest Airway Clearance System

K142482 is an FDA 510(k) clearance for The Vest Airway Clearance System, manufactured by Hill-Rom Services Private Limited. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K142482 · Hill-Rom Services Private Limited · Anesthesiology device
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May 2015
Decision
245d
Days
Class 2
Risk

K142482 is an FDA 510(k) clearance for the The Vest Airway Clearance System. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Hill-Rom Services Private Limited (Singapore, SG). The FDA issued a Cleared decision on May 7, 2015 after a review of 245 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 Hill-Rom Services Private Limited devices

FDA 510(k) Submission Details - K142482

510(k) Number K142482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2014
Decision Date May 07, 2015
Days to Decision 245 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
105d slower than avg
Panel avg: 140d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYI Device Classification - Class 2, Special Controls

Product Code BYI Percussor, Powered-electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
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 - BYI Percussor, Powered-electric

All 19
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K142482.
Electro Flo 6 Airway Clearance System
K201490 · Med Systems, Inc. · Feb 2021
AirPhysio Positive Expiratory Pressure (PEP) Device
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Monarch Airway Clearance System
K173603 · Hill-Rom Holdings, Inc. · Oct 2018
EMS PERCUSSOR
K913014 · Engineered Medical Systems · Oct 1991
FLEX-CUP PERCUSSOR
K892862 · Life Design Systems, Inc. · May 1989
MANUAL PERCUSSOR CUPS
K883899 · Medical Components, Inc. · Dec 1988