Cleared Traditional

K233441 - The Vest APX System (PVAPX1)

K233441 is an FDA 510(k) clearance for The Vest APX System (PVAPX1), manufactured by Baxter Healthcare Corportation. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K233441 · Baxter Healthcare Corportation · Anesthesiology device
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Mar 2024
Decision
156d
Days
Class 2
Risk

K233441 is an FDA 510(k) clearance for the The Vest APX System (PVAPX1). Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Baxter Healthcare Corportation (Deerfield Lake, US). The FDA issued a Cleared decision on March 22, 2024 after a review of 156 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 Baxter Healthcare Corportation devices

FDA 510(k) Submission Details - K233441

510(k) Number K233441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2023
Decision Date March 22, 2024
Days to Decision 156 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 140d · This submission: 156d
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 33
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