Cleared Traditional

K913014 - EMS PERCUSSOR

K913014 is an FDA 510(k) clearance for EMS PERCUSSOR, manufactured by Engineered Medical Systems. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K913014 · Engineered Medical Systems · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
107d
Days
Class 2
Risk

K913014 is an FDA 510(k) clearance for the EMS PERCUSSOR. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Engineered Medical Systems (Indianapolis, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 107 days - within the typical 510(k) review window.

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 Engineered Medical Systems devices

FDA 510(k) Submission Details - K913014

510(k) Number K913014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date October 23, 1991
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
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 18
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K913014.
Electro Flo 6 Airway Clearance System
K201490 · Med Systems, Inc. · Feb 2021
AirPhysio Positive Expiratory Pressure (PEP) Device
K203209 · Airphysio Pty, Ltd. · Jan 2021
Monarch Airway Clearance System
K173603 · Hill-Rom Holdings, Inc. · Oct 2018
FLEX-CUP PERCUSSOR
K892862 · Life Design Systems, Inc. · May 1989
MANUAL PERCUSSOR CUPS
K883899 · Medical Components, Inc. · Dec 1988
SALTER LABS 3000 SERIES PERCUSSORS
K863658 · Salter Labs · Oct 1986