Care Fusion: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Care Fusion” (first 2010, latest 2024), across 16 product codes in 5 review panels. Median 510(k) review time under this name: 170 days. Since 2017 the median was 189 days, against 181 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 | 5 | 81 |
| 2013 | 4 | 106 |
| 2014 | 3 | 13 |
| 2015 | 4 | 226 |
| 2016 | 3 | 256 |
| 2017 | 3 | 265 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 174 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 6 | 206 |
| 2024 | 1 | 166 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Care Fusion took a median 189 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 181 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 6 | 6 |
| DWM | Apparatus, Suction, Patient Care | 4 | 4 |
| HRX | Arthroscope | 4 | 4 |
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | 4 | 4 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| KNW | Instrument, Biopsy | 2 | 2 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 2 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
Plus 6 more product codes.
Review panels
- Anesthesiology (10)
- General Hospital (10)
- Orthopedic (6)
- Gastroenterology and Urology (5)
- General and Plastic Surgery (3)
Most recent Care Fusion 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device | LHI | 2024-03-06 | 166 |
| K231888 | BD Texium Needle-Free Syringe | FMF | 2023-09-25 | 90 |
| K221327 | BD Alaris Pump Infusion Sets | FPA | 2023-07-21 | 441 |
| K221319 | BD Alaris Pump Epidural Infusion Set | PWH | 2023-07-21 | 441 |
| K223101 | BD Secondary Infusion Set | FPA | 2023-05-12 | 224 |
| K223088 | BD SmartSite Needle-Free Connector | FPA | 2023-04-07 | 189 |
| K223076 | BD Texium Closed Male Luer | ONB | 2023-03-24 | 175 |
| K201155 | PleurX Peritoneal Catheter System | PNG | 2020-10-21 | 174 |
| K170405 | BD Curve Ascites Shunt | KPM | 2017-11-02 | 265 |
| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle | KNW | 2017-09-11 | 109 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Care Fusion.
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 Care Fusion (a text match, not an official crosswalk):
- A4648 — Tissue marker, implantable, any type, each (via NEU)
- G0379 — Direct admission of patient for hospital observation care (via DWM)
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.
- Care Essentials Pty, Ltd. (4 510(k)s)
- Care Rehab, Inc. (4 510(k)s)
- Care Wise Medical Products Corp. (4 510(k)s)
- Care Electronics, Inc. (3 510(k)s)
- Care Rehab and Orthopaedic (3 510(k)s)
- Care Systems, Inc. (3 510(k)s)
- Care Medical Devices, Inc. (2 510(k)s)
- Care Monitoring Systems (2 510(k)s)
- Care Technologies, Inc. (2 510(k)s)
- Care Diagnostic, Inc. (1 510(k)s)
- Care Fusion 213, LLC (1 510(k)s)
- Care Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Care Fusion?
FDA lists 34 510(k) clearances under the applicant name “Care Fusion” (first 2010, latest 2024), across 16 product codes in 5 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 Care Fusion?
The median time from FDA receipt to decision across 510(k)s cleared under the name Care Fusion is 170 days. Since 2017: 189 days, versus 181 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Care Fusion?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 6); DWM (Apparatus, Suction, Patient Care, 4); HRX (Arthroscope, 4).
Next steps
- See all 34 Care Fusion clearances with predicates and recalls
- Run predicate analysis for product code FPA, Care Fusion'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.