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Basen Bc-021

by Dongguan Yiyingmei Technology Co., Ltd.

Basen Bc-021 is a Class II device made by Dongguan Yiyingmei Technology Co., Ltd., cleared under FDA 510(k) K242028 on 19 Nov 2024 and listed in FDA GUDID since 31 Mar 2025 (UDI-DI 06978331170218), 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) K242028

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 Number06978331170218 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK242028 Date19 Nov 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242028 decided 19 Nov 2024 Active
  • FDA GUDID UDI-DI 06978331170218 listed 31 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242028
  2. Listed FDA GUDID 06978331170218

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Basen
Generic name
Nasal aspirator, electric
Model / reference
BC-021
Primary DI / UDI-DI
06978331170218
510(k) Number
FDA product code
BTA
GMDN term
Nasal aspirator, electric
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nasal aspirator, electric

Cleared under the same submission (K242028)

and 1 more cleared under K242028

Similar devices

Other devices filed under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Other devices from Dongguan Yiyingmei Technology Co., Ltd.

  • Basen Ym-805

    Class II

  • Basen Ym-808

    Class II

  • Basen Ym-801

    Class II

  • Basen Bc-025

    Class II

See all devices from Dongguan Yiyingmei Technology Co., Ltd. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)