Mckesson Israel , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mckesson Israel , Ltd.” (first 2012, latest 2015), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 133 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 121 |
| 2013 | 1 | 195 |
| 2014 | 1 | 151 |
| 2015 | 1 | 35 |
| 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (3)
- Radiology (2)
Most recent Mckesson Israel , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151850 | McKesson Cardiology | LLZ | 2015-08-11 | 35 |
| K133534 | MCKESSON CARDIOLOGY ECG MOBILE | DQK | 2014-04-18 | 151 |
| K131497 | MCKESSON CARDIOLOGY HEMO | MWI | 2013-12-05 | 195 |
| K113515 | HORIZON CARDIOLOGY ECG MANAGEMENT | DQK | 2012-03-16 | 109 |
| K112720 | MCKESSON HORIZON CARDIOLOGY | LLZ | 2012-01-30 | 133 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-03-12.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mckesson Corp. (5 510(k)s)
- Mckesson Medical Imaging Company (3 510(k)s)
- Mckesson Information Solutions, LLC (1 510(k)s)
- Mckesson Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mckesson Israel , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Mckesson Israel , Ltd.” (first 2012, latest 2015), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mckesson Israel , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mckesson Israel , Ltd. is 133 days.
Which FDA product codes appear under Mckesson Israel , Ltd.?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 2); LLZ (System, Image Processing, Radiological, 2); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 1).
Next steps
- See all 5 Mckesson Israel , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQK, Mckesson Israel , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.