Cleared Traditional

K012928 - ABI VEST AIRWAY CLEARANCE SYSTEM

K012928 is an FDA 510(k) clearance for ABI VEST AIRWAY CLEARANCE SYSTEM, manufactured by Advanced Respiratory. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K012928 · Advanced Respiratory · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
39d
Days
Class 2
Risk

K012928 is an FDA 510(k) clearance for the ABI VEST AIRWAY CLEARANCE SYSTEM. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Advanced Respiratory (St. Paul, US). The FDA issued a Cleared decision on October 9, 2001 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K012928

510(k) Number K012928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2001
Decision Date October 09, 2001
Days to Decision 39 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 140d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BYI Percussor, Powered-electric

All 54
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K012928.
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
K040367 · Electromed, Inc. · Apr 2004
ELECTRO FLO PERCUSSOR, MODEL 5000
K031876 · Med Systems · Nov 2003
THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
K024309 · Advanced Respiratory · Feb 2003
ABI VEST AIRWAY CLEARANCE SYSTEM
K993629 · American Biosystems, Inc. · Jan 2000
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
K982889 · Electromed, Inc. · Jun 1999
X-AIR-CISER
K974849 · Hougen Mfg., Inc. · Aug 1998
K012928 · ABI VEST AIRWAY CLEARANCE SYSTEM
Download PDF FDA Summary Advanced Respiratory