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Imed IM42074

by Bq Plus Medical Co., Ltd. 3 variants

Imed IM42074 is a Class II device made by Bq Plus Medical Co., Ltd., cleared under FDA 510(k) K210381 on 14 Aug 2021 and listed in FDA GUDID since 9 May 2022 (UDI-DI 26972620111146), 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) K210381

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 Number26972620111146 UDI-DI Date9 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210381 Date14 Aug 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210381 decided 14 Aug 2021 Active
  • FDA GUDID UDI-DI 26972620111146 listed 9 May 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210381
  2. Listed FDA GUDID 26972620111146

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Imed
Generic name
Basic intravenous administration set, noninvasive
Model / reference
IM42074
Primary DI / UDI-DI
26972620111146
FDA product code
FPA
GMDN term
Basic intravenous administration set, noninvasive
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Basic intravenous administration set, noninvasive

Cleared under the same submission (K210381)

and 8 more cleared under K210381

Other devices from Bq Plus Medical Co., Ltd.

See all devices from Bq Plus Medical Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)