Home / 510(k) Clearances / K250860

510(k) K250860

BreatheBand® (Model 1000) by Exemplar Medical, LLC — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2025
Date Received
March 21, 2025
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 for product code BYI

  • K242063 — LibAirty Airway Clearance System (December 19, 2024)
  • K240959 — Respiratory Muscle Trainer (December 18, 2024)
  • K233441 — The Vest APX System (PVAPX1) (March 22, 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)
  • K132794 — SMARTVEST AIRWAY CLEARANCE SYSTEM (December 19, 2013)