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510(k) K201114

Bidop 7 by Koven Technology, Inc. — Product Code DPW

K201114 is an FDA 510(k) premarket notification submitted by Koven Technology, Inc. for the device "Bidop 7". The FDA issued a decision of Substantially Equivalent on January 5, 2021. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Koven Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2021
Date Received
April 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Koven Technology, Inc.

  • K153762 — Smartdop XT6 (May 25, 2016)
  • K143332 — Fast Sphyg by Koven (April 14, 2015)
  • K131623 — SMARTDOP XT (January 17, 2014)
  • K080178 — VALVULOTOME BY KOVEN (July 28, 2008)
  • K050601 — SMARTDOP 45 VASCULAR DOPPLER (April 15, 2005)
  • K031931 — ECHO SOUNDER EX-101EX 8 MHZ (February 13, 2004)
  • K031504 — ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX (July 18, 2003)
  • K023143 — ECHO SOUNDER, ES-102EX (December 19, 2002)
  • K010452 — BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T (February 12, 2002)
  • K982986 — TUBING BLOOD FLOW METER MODEL NUMBER HD-800 (November 24, 1998)

Other clearances for product code DPW

  • K260700 — BlueDop Vascular Expert (July 8, 2026)
  • K252810 — FloPatch FP120 (April 24, 2026)
  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K251114 — FloPatch FP120 (June 20, 2025)
  • K243852 — Elfor-L (April 14, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K223843 — FloPatch FP120 (May 3, 2023)
  • K222242 — FloPatch FP120 (December 9, 2022)
  • K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2) (April 20, 2022)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)

FDA data resources