Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mckesson Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
7 daysmedian FDA review time
39 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K771175 | RESUSCITATOR, MS30 | Mckesson Corp. | 1977-08-02 | 34 | 0 |
| K761196 | NITROUS OXIDE SCAVENGING MASK | Mckesson Corp. | 1976-12-13 | 7 | 0 |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | Mckesson Corp. | 1976-12-09 | 3 | 0 |
| K761194 | HLR QUICK-FIT HEART-LUNG RESUSCITATOR | Mckesson Corp. | 1976-12-09 | 3 | 0 |
| K760017 | CONSIOUS SEDATION (ANALOR P-76) | Mckesson Corp. | 1976-07-20 | 39 | 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