Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Witt Biomedical Corporation · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
217 daysmedian FDA review time
273 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010058 | IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK | Witt Biomedical Corporation | 2001-03-21 | 72 | 0 |
| K973474 | WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT B | Witt Biomedical Corporation | 1998-03-13 | 182 | 0 |
| K950436 | WITT BIOMEDICAL SERIES IV | Witt Biomedical Corporation | 1995-11-02 | 273 | 0 |
| K945582 | WITT BIOMEDICAL IMAGE III | Witt Biomedical Corporation | 1995-06-19 | 217 | 0 |
| K923054 | WITT BIOMEDICAL SERIES II-EP | Witt Biomedical Corporation | 1993-02-25 | 246 | 0 |
| K880258 | WITT BIOMEDICAL VX-80 | Witt Biomedical Corporation | 1988-06-16 | 146 | 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