Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
D. E. Hokanson, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
282 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041689 | POLYURETHANE BLOOD PRESSURE CUFFS | D. E. Hokanson, Inc. | 2004-08-06 | 45 | 0 |
| K033156 | OB1 OBSTETRICAL DOPPLER | D. E. Hokanson, Inc. | 2003-12-09 | 70 | 0 |
| K023707 | A16 BLOOD FLOW MEASUREMENT SYSTEM | D. E. Hokanson, Inc. | 2003-02-12 | 100 | 0 |
| K982707 | EC6 PLETHYSMOGRAPH | D. E. Hokanson, Inc. | 1998-08-26 | 23 | 0 |
| K973426 | ANS 2000 ECG MONITOR AND RESPIRATION PACER | D. E. Hokanson, Inc. | 1998-08-12 | 336 | 0 |
| K970570 | NIVP3 (WINDOWS VERSION OF NIVP | D. E. Hokanson, Inc. | 1997-10-03 | 231 | 0 |
| K932852 | NON INVASIVE VASCULAR PROGRAM | D. E. Hokanson, Inc. | 1994-02-04 | 239 | 0 |
| K932812 | EC 5R PLETHYSMOGRAPH | D. E. Hokanson, Inc. | 1994-01-13 | 218 | 0 |
| K932851 | DISPOSABLE PENILE BLOOD PRESSURE CUFFS | D. E. Hokanson, Inc. | 1993-11-15 | 158 | 0 |
| K905367 | E-20 RAPID CUFF INFLATOR | D. E. Hokanson, Inc. | 1991-03-06 | 99 | 0 |
| K901592 | MODEL MD-5 DOPPLER | D. E. Hokanson, Inc. | 1990-10-22 | 200 | 0 |
| K896034 | PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM | D. E. Hokanson, Inc. | 1990-01-18 | 94 | 0 |
| K883908 | 3D VASCULAR RECORDER | D. E. Hokanson, Inc. | 1988-10-28 | 43 | 0 |
| K881055 | ECG MONITOR AND RESPIRATION PACER | D. E. Hokanson, Inc. | 1988-08-19 | 164 | 0 |
| K872517 | TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM | D. E. Hokanson, Inc. | 1987-10-01 | 99 | 0 |
| K842067 | CALCULATING CUFF INFLATOR TD312 | D. E. Hokanson, Inc. | 1985-03-01 | 282 | 0 |
| K840402 | AUDIO BANDWIDTH ANALYZER | D. E. Hokanson, Inc. | 1984-05-09 | 99 | 0 |
| K801291 | EC-4 PLETHYSMOGRAPH | D. E. Hokanson, Inc. | 1980-07-08 | 36 | 0 |
| K792015 | P-2 ULTRASONIC ARTERIOGRAPH | D. E. Hokanson, Inc. | 1979-12-04 | 60 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda