Cleared Traditional

K233441 - The Vest APX System (PVAPX1) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
17d slower than avg
Panel avg: 139d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 57
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