Mckesson Corp.: FDA clearances and approvals
Mckesson Corp. has 5 FDA 510(k) clearances (first 1976, latest 1977), across 5 product codes in 2 review panels. Median 510(k) review time: 7 days. It files with the SEC as MCKESSON CORP (MCK).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
| CAO | Airway, Esophageal (Obturator) | 1 | 1 |
| CBN | Apparatus, Gas-Scavenging | 1 | 1 |
| DRM | Compressor, Cardiac, External | 1 | 1 |
Review panels
- Anesthesiology (4)
- Cardiovascular (1)
Most recent Mckesson Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K771175 | RESUSCITATOR, MS30 | BTM | 1977-08-02 | 34 |
| K761196 | NITROUS OXIDE SCAVENGING MASK | CBN | 1976-12-13 | 7 |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | CAO | 1976-12-09 | 3 |
| K761194 | HLR QUICK-FIT HEART-LUNG RESUSCITATOR | DRM | 1976-12-09 | 3 |
| K760017 | CONSIOUS SEDATION (ANALOR P-76) | BZR | 1976-07-20 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Mckesson Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
MCKESSON CORP (MCK): EDGAR filings, CIK 927653. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Mckesson Corp. have?
Mckesson Corp. has 5 FDA 510(k) clearances (first 1976, latest 1977), across 5 product codes in 2 review panels.
How long does FDA take to clear Mckesson Corp.'s 510(k)s?
The median time from FDA receipt to decision across Mckesson Corp.'s cleared 510(k)s is 7 days.
What devices does Mckesson Corp. make?
Its most frequent FDA product codes are BTM (Ventilator, Emergency, Manual (Resuscitator), 1); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 1); CAO (Airway, Esophageal (Obturator), 1).
Has Mckesson Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mckesson Corp. Related entities may recall under other names.
Next steps
- See all 5 Mckesson Corp. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Mckesson Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.