Cardinal Health200, LLC: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Cardinal Health200, LLC” (first 2011, latest 2024), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 118 days. Since 2017 the median was 121 days, against 134 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 | 3 | 100 |
| 2013 | 3 | 76 |
| 2014 | 1 | 149 |
| 2015 | 3 | 139 |
| 2016 | 1 | 171 |
| 2017 | 2 | 185 |
| 2018 | 1 | 223 |
| 2019 | 2 | 148 |
| 2020 | 2 | 115 |
| 2021 | 2 | 293 |
| 2022 | 0 | — |
| 2023 | 3 | 122 |
| 2024 | 1 | 64 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cardinal Health200, LLC took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRG | Wrap, Sterilization | 11 | 11 |
| FYA | Gown, Surgical | 4 | 4 |
| FXX | Mask, Surgical | 3 | 3 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| MEG | Syringe, Antistick | 1 | 1 |
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | 1 | 1 |
Review panels
- General Hospital (25)
- Cardiovascular (1)
Most recent Cardinal Health200, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241780 | Cardinal Health Nitrile Exam Gloves | LZA | 2024-08-23 | 64 |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets | FYA | 2023-07-27 | 122 |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) | MEG | 2023-06-21 | 229 |
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly | JOW | 2023-04-03 | 89 |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove | KGO | 2021-09-26 | 471 |
| K211390 | Nitrile Blue Powder-free Examination Glove | LZA | 2021-08-28 | 115 |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown | FYA | 2020-07-29 | 121 |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve | FYA | 2020-03-20 | 109 |
| K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip | FXX | 2019-12-02 | 94 |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | QPC | 2019-04-26 | 203 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardinal Health200, LLC.
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. (26 510(k)s)
- Cardinal Health, Alaris Products (9 510(k)s)
- Cardinal Health-Medical Products and Services (6 510(k)s)
- Cardinal Health 207, Inc. (5 510(k)s)
- Cardinal Health 303,Inc. (4 510(k)s)
- Cardinal Spine, LLC (4 510(k)s)
- Cardinal Health 200, Inc. (3 510(k)s)
- Cardinal Health Germany 234 GmbH (2 510(k)s)
- Cardinal Health, LLC (2 510(k)s)
- Cardinal Health 200, LLC (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 Health200, LLC?
FDA lists 26 510(k) clearances under the applicant name “Cardinal Health200, LLC” (first 2011, latest 2024), across 10 product codes in 2 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 Health200, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardinal Health200, LLC is 118 days. Since 2017: 121 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cardinal Health200, LLC?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 11); FYA (Gown, Surgical, 4); FXX (Mask, Surgical, 3).
Next steps
- See all 26 Cardinal Health200, LLC clearances with predicates and recalls
- Run predicate analysis for product code FRG, Cardinal Health200, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.