Skip to content

Smartdop 45

by Koven Technology, Inc.

Smartdop 45 is a Class II device made by Koven Technology, Inc., cleared under FDA 510(k) K050601 on 15 Apr 2005 and listed in FDA GUDID since 24 Feb 2016 (UDI-DI 00894912002135), active as of 15 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 15 Oct 2026

Documents

510(k) K050601

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 15 Oct 2026.

Regulatory status

as of registry sync 15 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00894912002135 UDI-DI Date24 Feb 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050601 Date15 Apr 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050601 decided 15 Apr 2005 Active
  • FDA GUDID UDI-DI 00894912002135 listed 24 Feb 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050601
  2. Listed FDA GUDID 00894912002135

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Vascular ultrasound system control unit
Model / Ref / Catalog
Smartdop 45
Primary DI / UDI-DI
00894912002135
510(k) Number
FDA product code
IYN, ITX, DPW
GMDN term
Vascular ultrasound system control unit
Device class
Class II
Regulation number
892.1550, 892.1570, 870.2100
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Vascular ultrasound system control unit

Similar devices

Other devices filed under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Other devices from Koven Technology, Inc.

  • BT8M05S8A

    Class II

  • Pg-01

    Class II

  • VRP Probe VRP-20

    Class II

  • Hd-307 HD307--8

    Class II

See all devices from Koven Technology, Inc. →

Properties

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