Data / Medical devices / United States / Koven Technology, Inc.
Koven Technology, Inc.: FDA-registered device maker in Saint Louis, MO, United States, 1 510(k) clearance
Koven Technology, Inc. is registered with the FDA (registration 1937397) in Saint Louis, MO, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 14, 2015. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1937397
- Address
- 625 Maryville Centre Dr Ste 300, Saint Louis, MO, United States, 63141
- Owner or operator
- KOVEN TECHNOLOGY, INC. (1937397)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 20, 2015
- Registered through
- 2027
- Brand names listed
- CT-1, CT-2, CT-4, CT-6, CT-7, CT-XT, FAST Sphyg by Koven, PAUS2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 14, 2015 | K143332 | Fast Sphyg by Koven | DXQ | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 4, 2026 | 98556 | Class II | Ongoing | 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, | Product labeling includes a fetal indication for use that is not cleared under its 510(k). | accessdata.fda.gov |
Compare with other makers
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- All makers of System, Digital Image Communications, Radiological
- All makers of Blood Pressure Cuff
Updated March 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.