Koven Technology, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Koven Technology, Inc.” (first 1994, latest 2021), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 198 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 227 |
| 2015 | 1 | 145 |
| 2016 | 1 | 147 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 253 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Koven Technology, Inc. took a median 253 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | 7 | 7 |
| JOP | Transducer, Ultrasonic | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| KNG | Monitor, Ultrasonic, Fetal | 2 | 2 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| LEL | Device, Sleep Assessment | 1 | 1 |
| MGZ | Valvulotome | 1 | 1 |
Review panels
- Cardiovascular (12)
- Radiology (3)
- Obstetrics and Gynecology (2)
- Neurology (1)
Most recent Koven Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201114 | Bidop 7 | DPW | 2021-01-05 | 253 |
| K153762 | Smartdop XT6 | JOP | 2016-05-25 | 147 |
| K143332 | Fast Sphyg by Koven | DXQ | 2015-04-14 | 145 |
| K131623 | SMARTDOP XT | JOP | 2014-01-17 | 227 |
| K080178 | VALVULOTOME BY KOVEN | MGZ | 2008-07-28 | 186 |
| K050601 | SMARTDOP 45 VASCULAR DOPPLER | DPW | 2005-04-15 | 37 |
| K031931 | ECHO SOUNDER EX-101EX 8 MHZ | DPW | 2004-02-13 | 235 |
| K031504 | ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX | KNG | 2003-07-18 | 65 |
| K023143 | ECHO SOUNDER, ES-102EX | KNG | 2002-12-19 | 90 |
| K010452 | BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T | DPW | 2002-02-12 | 362 |
8 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-03-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Koven and Assoc., Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Koven Technology, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Koven Technology, Inc.” (first 1994, latest 2021), across 8 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Koven Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Koven Technology, Inc. is 198 days.
Which FDA product codes appear under Koven Technology, Inc.?
The most frequent FDA product codes under this applicant name are DPW (Flowmeter, Blood, Cardiovascular, 7); JOP (Transducer, Ultrasonic, 3); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 18 Koven Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPW, Koven Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.