Cardinal Health-Medical Products and Services: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cardinal Health-Medical Products and Services” (first 2011, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 129 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Cardinal Health, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 116 |
| 2013 | 2 | 146 |
| 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 3 | 3 |
| KGO | Surgeon'S Gloves | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Cardinal Health-Medical Products and Services 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132060 | DURABLUE STERILIZATION WRAP | FRG | 2013-12-13 | 163 |
| K123289 | DURABLUE STERILIZATION WRAP | FRG | 2013-02-28 | 129 |
| K120542 | CARDINAL HEALTH DURABLUE STERILIZATION WRAP | FRG | 2012-06-01 | 99 |
| K113707 | STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING | KGO | 2012-04-27 | 133 |
| K111868 | STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING | KGO | 2011-09-21 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Cardinal Health-Medical Products and Services.
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 207, Inc. (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-Medical Products and Services?
FDA lists 5 510(k) clearances under the applicant name “Cardinal Health-Medical Products and Services” (first 2011, latest 2013), 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 Cardinal Health-Medical Products and Services?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardinal Health-Medical Products and Services is 129 days.
Which FDA product codes appear under Cardinal Health-Medical Products and Services?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 3); KGO (Surgeon'S Gloves, 2).
Next steps
- See all 5 Cardinal Health-Medical Products and Services clearances with predicates and recalls
- Run predicate analysis for product code FRG, Cardinal Health-Medical Products and Services'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.