Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medionics International , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
363 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910173 | SELECTRA AND TUBING SETS | Medionics International , Ltd. | 1992-01-13 | 363 | 0 |
| K883393 | CAPD DISPOSABLE Y SYSTEM - DY SET | Medionics International , Ltd. | 1988-11-03 | 86 | 0 |
| K842305 | C.A.P.D. AUTOMATIC HEATER PDH 200 | Medionics International , Ltd. | 1984-06-25 | 13 | 0 |
| K831766 | MICROSTAR VCI | Medionics International , Ltd. | 1983-10-14 | 135 | 0 |
| K832141 | MICROSTAR VC1 VOLUMETRIC CYCLER | Medionics International , Ltd. | 1983-10-14 | 101 | 0 |
| K821328 | C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP | Medionics International , Ltd. | 1982-07-28 | 85 | 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