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BiDop 3

by Koven Technology, Inc.

BiDop 3 (ES-100V3) is a Class II device made by Koven Technology, Inc., cleared under FDA 510(k) K954397 on 29 Mar 1996 and listed in FDA GUDID since 24 Feb 2016 (UDI-DI 00894912002043), active as of 22 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K954397

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00894912002043 UDI-DI Date24 Feb 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK954397 Date29 Mar 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K954397 decided 29 Mar 1996 Active
  • FDA GUDID UDI-DI 00894912002043 listed 24 Feb 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1631-2026 FDA Class II initiated 4 Mar 2026

    Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Timeline

3 dated events

  1. Cleared FDA 510(k) K954397
  2. Listed FDA GUDID 00894912002043
  3. Recall initiated FDA recalls Z-1631-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Noninvasive vascular ultrasound system
Model / Ref / Catalog
BiDop 3, ES-100V3
Primary DI / UDI-DI
00894912002043
510(k) Number
FDA product code
DPW, JOP
GMDN term
Noninvasive vascular ultrasound system
Device class
Class II
Regulation number
870.2100, 870.2880
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Noninvasive vascular ultrasound system

Similar devices

Other devices filed under FDA product code DPW (Flowmeter, Blood, Cardiovascular).

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See all devices from Koven Technology, Inc. →

Properties

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