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Smartvest Clearway-I Air Pulse Generator

by Electromed, Inc.

Smartvest Clearway-I Air Pulse Generator is a Class II device made by Electromed, Inc., cleared under FDA 510(k) K222496 on 18 Nov 2022 and listed in FDA GUDID since 17 Feb 2023 (UDI-DI B102125003S0200), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K222496

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB102125003S0200 UDI-DI Date17 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK222496 Date18 Nov 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222496 decided 18 Nov 2022 Active
  • FDA GUDID UDI-DI B102125003S0200 listed 17 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222496
  2. Listed FDA GUDID B102125003S0200

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Smartvest
Generic name
Chest-oscillation airway secretion-clearing system generator
Model / Ref / Catalog
Clearway-I Air Pulse Generator, Clearway-I
Primary DI / UDI-DI
B102125003S0200
510(k) Number
FDA product code
BYI
GMDN term
Chest-oscillation airway secretion-clearing system generator
Device class
Class II
Regulation number
868.5665
GUDID distribution status
In Commercial Distribution

Related devices

Category: Chest-oscillation airway secretion-clearing system generator

Cleared under the same submission (K222496)

Similar devices

Other devices filed under FDA product code BYI (Percussor, Powered-Electric).

Other devices from Electromed, Inc.

See all devices from Electromed, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)