Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Instrumentation & Diagnostics Corp.(Midco) · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
359 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991336 | BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTH | Medical Instrumentation & Diagnostics Corp.(Midco) | 1999-07-12 | 84 | 0 |
| K961484 | CASS SYSTEM (MODIFICATION) | Medical Instrumentation & Diagnostics Corp.(Midco) | 1996-11-07 | 223 | 0 |
| K921740 | COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED | Medical Instrumentation & Diagnostics Corp.(Midco) | 1993-04-07 | 359 | 0 |
| K911750 | COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED | Medical Instrumentation & Diagnostics Corp.(Midco) | 1991-10-15 | 180 | 0 |
| K902488 | MODIFIED CASS SYSTEM | Medical Instrumentation & Diagnostics Corp.(Midco) | 1990-12-07 | 191 | 0 |
| K894263 | CASS SYSTEM | Medical Instrumentation & Diagnostics Corp.(Midco) | 1989-09-01 | 73 | 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