Cardinalhealth: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Cardinalhealth” (first 2003, latest 2026), plus 1 PMA decision, across 20 product codes in 7 review panels. Median 510(k) review time under this name: 124 days. Since 2017 the median was 212 days, against 136 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 5 | 182 |
| 2016 | 0 | — |
| 2017 | 2 | 182 |
| 2018 | 0 | — |
| 2019 | 1 | 212 |
| 2020 | 1 | 463 |
| 2021 | 1 | 302 |
| 2022 | 1 | 233 |
| 2023 | 1 | 124 |
| 2024 | 1 | 23 |
| 2025 | 1 | 268 |
| 2026 | 2 | 135 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cardinalhealth took a median 212 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 7 | 7 |
| KGO | Surgeon'S Gloves | 4 | 4 |
| LZC | Medical Glove, Specialty | 3 | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 | 1 |
| HCH | Clip, Aneurysm | 1 | 1 |
Plus 10 more product codes.
Review panels
- General Hospital (12)
- General and Plastic Surgery (8)
- Anesthesiology (4)
- Gastroenterology and Urology (3)
- Neurology (3)
- Orthopedic (3)
- Cardiovascular (1)
Most recent Cardinalhealth 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2026-09-02 | 97 |
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | LZC | 2026-01-14 | 173 |
| K243660 | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoject 6mL Syringe, Luer-Lock Tip (1180600777); Monoject 12mL Syringe, Luer-Lock Tip (1181200777); Monoject 20mL Syringe, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | FMF | 2025-08-22 | 268 |
| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE) | PNR | 2024-12-19 | 23 |
| K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) | FXX | 2023-07-03 | 124 |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | PIF | 2022-05-19 | 233 |
| K202217 | Kendall NPWT Incision Management Device | OMP | 2021-06-04 | 302 |
| K191101 | Kendall NPWT Incision Management Dressing Kit | OMP | 2020-07-31 | 463 |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | PIF | 2019-11-07 | 212 |
| K171499 | Occlusion Detection Dressing Kit | OMP | 2017-09-22 | 122 |
23 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P190007 | PMA | Cardinal Health Multifunctional Defibrillation Electrode | 2020-08-07 |
Recalls
openFDA lists no recalls under a recalling firm named Cardinalhealth.
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 Cardinalhealth (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardinalhealth?
FDA lists 33 510(k) clearances under the applicant name “Cardinalhealth” (first 2003, latest 2026), plus 1 PMA decision, across 20 product codes in 7 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 Cardinalhealth?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardinalhealth is 124 days. Since 2017: 212 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cardinalhealth?
The most frequent FDA product codes under this applicant name are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 7); KGO (Surgeon'S Gloves, 4); LZC (Medical Glove, Specialty, 3).
Next steps
- See all 33 Cardinalhealth clearances with predicates and recalls
- Run predicate analysis for product code OMP, Cardinalhealth'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.