Cleared Traditional

K982889 - MEDPULSE RESPIRATORY VEST SYSTEM

K982889 is an FDA 510(k) clearance for MEDPULSE RESPIRATORY VEST SYSTEM, manufactured by Electromed, Inc.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K982889 · Electromed, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
288d
Days
Class 2
Risk

K982889 is an FDA 510(k) clearance for the MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Electromed, Inc. (Minnetonka, US). The FDA issued a Cleared decision on June 1, 1999 after a review of 288 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 Electromed, Inc. devices

FDA 510(k) Submission Details - K982889

510(k) Number K982889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1998
Decision Date June 01, 1999
Days to Decision 288 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
148d slower than avg
Panel avg: 140d · This submission: 288d
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
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