Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Howtek, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
199 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021949 | FULCRUM | Howtek, Inc. | 2002-08-12 | 60 | 0 |
| K973081 | DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0 | Howtek, Inc. | 1997-11-05 | 79 | 0 |
| K972191 | DIGITIZER DIRECTOR (HSC025-01) | Howtek, Inc. | 1997-09-08 | 90 | 0 |
| K970908 | HOWTEK 960 | Howtek, Inc. | 1997-05-20 | 70 | 0 |
| K953117 | SCANMASTER DX | Howtek, Inc. | 1996-01-18 | 199 | 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