Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ziosoft, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
130 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200315 | Ziostation2 | Ziosoft, Inc. | 2020-05-05 | 88 | 0 |
| K181892 | Ziostation2 | Ziosoft, Inc. | 2018-10-09 | 88 | 0 |
| K091262 | MR CARDIAC FUNCTION ANALYSIS | Ziosoft, Inc. | 2009-06-29 | 61 | 0 |
| K083446 | CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING | Ziosoft, Inc. | 2009-03-31 | 130 | 0 |
| K083084 | CT BRAIN PERFUSION FOR ZIOSTATION | Ziosoft, Inc. | 2008-12-19 | 64 | 0 |
| K070205 | ZIOSTATION | Ziosoft, Inc. | 2007-03-23 | 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