Koven and Assoc., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Koven and Assoc., Inc.” (first 1989, latest 1993), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 229 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | 5 | 5 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| JOP | Transducer, Ultrasonic | 1 | 1 |
Review panels
- Cardiovascular (8)
Most recent Koven and Assoc., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922669 | MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW | DPW | 1993-01-29 | 239 |
| K920333 | SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR | DPW | 1993-01-22 | 361 |
| K915550 | MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR | DPW | 1992-12-10 | 365 |
| K913595 | DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | DXN | 1992-03-27 | 227 |
| K912409 | MODEL HD-207 BIDIRECTIONAL VELOCITY METER | JOP | 1991-12-23 | 206 |
| K903026 | ES-1000SP II SMART DOP | DPW | 1991-02-26 | 231 |
| K894892 | HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM | DSB | 1989-10-27 | 87 |
| K892707 | DVM-4200 BLOOD FLOWMETER | DPW | 1989-07-28 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Koven and Assoc., Inc..
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 Technology, Inc. (18 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Koven and Assoc., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Koven and Assoc., Inc.” (first 1989, latest 1993), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Koven and Assoc., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Koven and Assoc., Inc. is 229 days.
Which FDA product codes appear under Koven and Assoc., Inc.?
The most frequent FDA product codes under this applicant name are DPW (Flowmeter, Blood, Cardiovascular, 5); DSB (Plethysmograph, Impedance, 1); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Next steps
- See all 8 Koven and Assoc., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPW, Koven and Assoc., 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.