Cardinal Health, Alaris Products: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Cardinal Health, Alaris Products” (first 2005, latest 2007), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 79 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 BD (Becton, Dickinson and Company), based on public ownership records.
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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Review panels
- General Hospital (9)
Most recent Cardinal Health, Alaris Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071400 | SMARTSITE STOPCOCK | FMG | 2007-12-14 | 207 |
| K071108 | TEXIUM SYRINGE | FMF | 2007-05-24 | 35 |
| K061285 | SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS | FPA | 2006-07-26 | 79 |
| K053049 | ALARIS SAFETY MALE LUER | FPA | 2006-01-12 | 76 |
| K052790 | SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD | LHI | 2005-12-23 | 81 |
| K051641 | ALARIS SYSTEM PC UNIT, MODEL 8001 | FRN | 2005-10-20 | 122 |
| K050115 | BLOOD HAND PUMP ADMINISTRATION SET | BRZ | 2005-04-01 | 73 |
| K043590 | SE INFUSION SYSTEM WITH MMS | FRN | 2005-03-25 | 87 |
| K050230 | TURBO TEMP TRIO | FLL | 2005-02-16 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Cardinal Health, Alaris Products.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Cardinal Health, Alaris Products (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 207, Inc. (5 510(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, Alaris Products?
FDA lists 9 510(k) clearances under the applicant name “Cardinal Health, Alaris Products” (first 2005, latest 2007), across 7 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, Alaris Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardinal Health, Alaris Products is 79 days.
Which FDA product codes appear under Cardinal Health, Alaris Products?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 2); FRN (Pump, Infusion, 2); BRZ (Set, Blood Transfusion, 1).
Next steps
- See all 9 Cardinal Health, Alaris Products clearances with predicates and recalls
- Run predicate analysis for product code FPA, Cardinal Health, Alaris Products'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.