D. E. Hokanson, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “D. E. Hokanson, Inc.” (first 1979, latest 2004), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 99 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 |
|---|---|---|---|
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 5 | 5 |
| DPS | Electrocardiograph | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| DXQ | Blood Pressure Cuff | 2 | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| JEH | Plethysmograph, Volume | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (15)
- Anesthesiology (1)
- Clinical Chemistry (1)
- Obstetrics and Gynecology (1)
- Radiology (1)
Most recent D. E. Hokanson, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041689 | POLYURETHANE BLOOD PRESSURE CUFFS | DXQ | 2004-08-06 | 45 |
| K033156 | OB1 OBSTETRICAL DOPPLER | KNG | 2003-12-09 | 70 |
| K023707 | A16 BLOOD FLOW MEASUREMENT SYSTEM | JOM | 2003-02-12 | 100 |
| K982707 | EC6 PLETHYSMOGRAPH | JOM | 1998-08-26 | 23 |
| K973426 | ANS 2000 ECG MONITOR AND RESPIRATION PACER | DPS | 1998-08-12 | 336 |
| K970570 | NIVP3 (WINDOWS VERSION OF NIVP | DQK | 1997-10-03 | 231 |
| K932852 | NON INVASIVE VASCULAR PROGRAM | JOB | 1994-02-04 | 239 |
| K932812 | EC 5R PLETHYSMOGRAPH | JEH | 1994-01-13 | 218 |
| K932851 | DISPOSABLE PENILE BLOOD PRESSURE CUFFS | DXQ | 1993-11-15 | 158 |
| K905367 | E-20 RAPID CUFF INFLATOR | DXN | 1991-03-06 | 99 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named D. E. Hokanson, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under D. E. Hokanson, Inc.?
FDA lists 19 510(k) clearances under the applicant name “D. E. Hokanson, Inc.” (first 1979, latest 2004), across 12 product codes in 5 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 D. E. Hokanson, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name D. E. Hokanson, Inc. is 99 days.
Which FDA product codes appear under D. E. Hokanson, Inc.?
The most frequent FDA product codes under this applicant name are JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, 5); DPS (Electrocardiograph, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2).
Next steps
- See all 19 D. E. Hokanson, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOM, D. E. Hokanson, 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.