Cardinal Health 207, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cardinal Health 207, Inc.” (first 2008, latest 2010), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 159 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 3 | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Cardinal Health 207, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093094 | VELA VENTILATOR | CBK | 2010-05-11 | 222 |
| K092484 | HELIOX LOW FLOW SENTRY BLENDER | BZR | 2010-04-02 | 232 |
| K093124 | PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 | BZD | 2010-03-10 | 159 |
| K081670 | THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK | CBK | 2008-10-09 | 118 |
| K081837 | AVEA VENTILATOR | CBK | 2008-08-13 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Cardinal Health 207, Inc..
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.
- Cardinal Health, Inc. (28 510(k)s)
- Cardinal Health200, LLC (26 510(k)s)
- Cardinal Health, Alaris Products (9 510(k)s)
- Cardinal Health-Medical Products and Services (5 510(k)s)
- Cardinal Health 200, Inc. (4 510(k)s)
- Cardinal Health 303,Inc. (4 510(k)s)
- Cardinal Spine, LLC (4 510(k)s)
- Cardinal Health Germany 234 GmbH (2 510(k)s)
- Cardinal Health,Medical Products and Services (1 510(k)s)
- Cardinal Scale Mfg. Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardinal Health 207, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Cardinal Health 207, Inc.” (first 2008, latest 2010), across 3 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 Cardinal Health 207, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardinal Health 207, Inc. is 159 days.
Which FDA product codes appear under Cardinal Health 207, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 3); BZD (Ventilator, Non-Continuous (Respirator), 1); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 1).
Next steps
- See all 5 Cardinal Health 207, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Cardinal Health 207, Inc.'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.