Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mckesson Israel , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
195 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151850 | McKesson Cardiology | Mckesson Israel , Ltd. | 2015-08-11 | 35 | 0 |
| K133534 | MCKESSON CARDIOLOGY ECG MOBILE | Mckesson Israel , Ltd. | 2014-04-18 | 151 | 0 |
| K131497 | MCKESSON CARDIOLOGY HEMO | Mckesson Israel , Ltd. | 2013-12-05 | 195 | 7 |
| K113515 | HORIZON CARDIOLOGY ECG MANAGEMENT | Mckesson Israel , Ltd. | 2012-03-16 | 109 | 1 |
| K112720 | MCKESSON HORIZON CARDIOLOGY | Mckesson Israel , Ltd. | 2012-01-30 | 133 | 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