Koven Technology, Inc.
FDA Regulatory Profile
Koven Technology, Inc. appears in FDA public data with 1 recall, 18 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1631-2026, Class II) was initiated on March 4, 2026. Its most recent 510(k) clearance was granted on January 5, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 18
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1631-2026 | Class II | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Mod | March 4, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201114 | Bidop 7 | January 5, 2021 |
| 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 |
| K961817 | B SMART MODEL 1 | July 23, 1997 |
| K963274 | V-LINK 3.2 FOR WINDOWS | October 31, 1996 |
| K951449 | MODEL KM-25 | May 20, 1996 |
| K954397 | BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY | March 29, 1996 |
| K935994 | PW DOPPLER VASCULAR PROBES | May 11, 1995 |
| K942613 | SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR | December 23, 1994 |
| K934638 | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 | May 13, 1994 |