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Bar Code Reader Kit 50-372

by Aktina Corp.

Bar Code Reader Kit 50-372 is a barcode reader (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Aktina Corp., cleared under FDA 510(k) K161984 on 27 Sep 2016 and listed in FDA GUDID since 21 May 2021 (UDI-DI B365503720), 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) K161984

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 NumberB365503720 UDI-DI Date21 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161984 Date27 Sep 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161984 decided 27 Sep 2016 Active
  • FDA GUDID UDI-DI B365503720 listed 21 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161984
  2. Listed FDA GUDID B365503720

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bar Code Reader Kit
Generic name
Barcode reader
Model / reference
50-372
Primary DI / UDI-DI
B365503720
510(k) Number
FDA product code
IYE
GMDN term
Barcode reader
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

Other devices from Aktina Corp.

See all devices from Aktina Corp. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)