Cardinal Health, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Cardinal Health, Inc.” (first 2006, latest 2022), across 13 product codes in 6 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 168 days, against 119 days for all cleared 510(k)s in the same product codes. 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 | 42 |
| 2013 | 1 | 149 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 160 |
| 2017 | 1 | 143 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 168 |
| 2022 | 1 | 201 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cardinal Health, Inc. took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 13 | 13 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GYC | Electrode, Cortical | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Plus 3 more product codes.
Review panels
- General Hospital (20)
- Neurology (2)
- Orthopedic (2)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
Most recent Cardinal Health, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI | LZH | 2022-12-20 | 201 |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown | FYA | 2021-11-23 | 168 |
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) | KGO | 2017-06-15 | 143 |
| K160411 | Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating | LYZ | 2016-07-25 | 160 |
| K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | KGO | 2016-07-11 | 103 |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | KGO | 2016-05-12 | 177 |
| K122696 | POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) | LZA | 2013-01-31 | 149 |
| K121897 | PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES | KGO | 2012-07-27 | 28 |
| K120934 | PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS | KGO | 2012-05-23 | 56 |
| K111878 | PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES | KGO | 2011-09-29 | 90 |
18 earlier clearances. See the full list in Caduvo.
Recalls
161 product recalls in 44 recall events; 17 initiated in the last five years. Most recent: 2022-11-01.
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.
SEC filings
CARDINAL HEALTH INC (CAH): EDGAR filings, CIK 721371. An SEC registrant with the same name, matched by name only.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Cardinal Health, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZH)
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 Health200, LLC (26 510(k)s)
- Cardinal Health, Alaris Products (9 510(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, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Cardinal Health, Inc.” (first 2006, latest 2022), across 13 product codes in 6 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 Cardinal Health, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardinal Health, Inc. is 104 days. Since 2017: 168 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cardinal Health, Inc.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 13); LZA (Polymer Patient Examination Glove, 3); NDN (Cement, Bone, Vertebroplasty, 2).
Next steps
- See all 28 Cardinal Health, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Cardinal Health, 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.