Narco Mckesson Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Narco Mckesson Co.” (first 1978, latest 1980), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 19 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 | 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 5 | 5 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
Review panels
- Anesthesiology (6)
Most recent Narco Mckesson Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K801102 | COMPALOR-ORAL SURGERY MODEL | BSZ | 1980-06-17 | 39 |
| K801101 | ANALOR FOUR-ORAL SURGERY MODEL | BZE | 1980-06-17 | 39 |
| K801103 | COMPALOR-DENTAL MODEL | BSZ | 1980-05-28 | 19 |
| K801100 | ANALOR FOUR-DENTAL MODEL | BSZ | 1980-05-28 | 19 |
| K790456 | SERIES 7000 | BSZ | 1979-03-23 | 17 |
| K781492 | SERIES 7000 GAS MACHINE | BSZ | 1978-09-11 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Narco Mckesson Co..
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.
- Narco Scientific (30 510(k)s)
- Narco Air-Shields (19 510(k)s)
- Narco Bio-Systems (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Narco Mckesson Co.?
FDA lists 6 510(k) clearances under the applicant name “Narco Mckesson Co.” (first 1978, latest 1980), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Narco Mckesson Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Narco Mckesson Co. is 19 days.
Which FDA product codes appear under Narco Mckesson Co.?
The most frequent FDA product codes under this applicant name are BSZ (Gas-Machine, Anesthesia, 5); BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, 1).
Next steps
- See all 6 Narco Mckesson Co. clearances with predicates and recalls
- Run predicate analysis for product code BSZ, Narco Mckesson Co.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.