Koven Technology, Inc.
Saint Louis, MO, US
KOVEN TECHNOLOGY, INC. appears in FDA device records in Saint Louis, MO. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Koven Technology, Inc. between 1994 and 2021. The busiest year on record is 1996, with 3. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201114 | Bidop 7 | DPW | Substantially Equivalent | |
| K153762 | Smartdop XT6 | JOP | Substantially Equivalent | |
| K143332 | Fast Sphyg by Koven | DXQ | Substantially Equivalent | |
| K131623 | SMARTDOP XT | JOP | Substantially Equivalent | |
| K080178 | VALVULOTOME BY KOVEN | MGZ | Substantially Equivalent | |
| K050601 | SMARTDOP 45 VASCULAR DOPPLER | DPW | Substantially Equivalent | |
| K031931 | ECHO SOUNDER EX-101EX 8 MHZ | DPW | Substantially Equivalent | |
| K031504 | ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX | KNG | Substantially Equivalent | |
| K023143 | ECHO SOUNDER, ES-102EX | KNG | Substantially Equivalent | |
| K010452 | BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T | DPW | Substantially Equivalent | |
| K982986 | TUBING BLOOD FLOW METER MODEL NUMBER HD-800 | DPW | Substantially Equivalent | |
| K961817 | B SMART MODEL 1 | LEL | Substantially Equivalent | |
| K963274 | V-LINK 3.2 FOR WINDOWS | IYO | Substantially Equivalent | |
| K951449 | MODEL KM-25 | IYO | Substantially Equivalent | |
| K954397 | BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY | DPW | Substantially Equivalent | |
| K935994 | PW DOPPLER VASCULAR PROBES | ITX | Substantially Equivalent | |
| K942613 | SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR | DPW | Substantially Equivalent | |
| K934638 | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 | JOP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1937397 | 1937397 | KOVEN TECHNOLOGY, INC. | 625 Maryville Centre Dr Ste 300, Saint Louis, MO 63141 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DXQBlood Pressure Cuff
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- LELDevice, Sleep Assessment
- DPWFlowmeter, Blood, Cardiovascular
- KNGMonitor, Ultrasonic, Fetal
- JAFMonitor, Ultrasonic, Nonfetal
- LMDSystem, Digital Image Communications, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- MGZValvulotome
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1631-2026 | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications. | Product labeling includes a fetal indication for use that is not cleared under its 510(k). | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain