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510(k) K233441

The Vest APX System (PVAPX1) by Baxter Healthcare Corportation — Product Code BYI

K233441 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corportation for the device "The Vest APX System (PVAPX1)". The FDA issued a decision of Substantially Equivalent on March 22, 2024. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Baxter Healthcare Corportation has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2024
Date Received
October 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

Other clearances by Baxter Healthcare Corportation

  • K201809 — AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory (March 10, 2021)
  • K193137 — EASYGRIP FLO-41 Precision MIS Delivery System (January 8, 2020)

Other clearances for product code BYI

  • K252849 — AffloVest® Mobile Airway Clearance Therapy (April 30, 2026)
  • K250860 — BreatheBand® (Model 1000) (October 2, 2025)
  • K242063 — LibAirty Airway Clearance System (December 19, 2024)
  • K240959 — Respiratory Muscle Trainer (December 18, 2024)
  • K222496 — Electromed SmartVest Airway Clearance System (November 18, 2022)
  • K201490 — Electro Flo 6 Airway Clearance System (February 12, 2021)
  • K203209 — AirPhysio Positive Expiratory Pressure (PEP) Device (January 15, 2021)
  • K173603 — Monarch Airway Clearance System (October 24, 2018)
  • K163378 — Monarch Airway Clearance System (March 17, 2017)
  • K142482 — The Vest Airway Clearance System (May 7, 2015)

FDA data resources