Carefusion 2200, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under 2 spellings of the applicant name “Carefusion 2200, Inc.” (first 2009, latest 2021), across 8 product codes in 6 review panels. Median 510(k) review time under this name: 127 days. Since 2017 the median was 133 days, against 116 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 BD (Becton, Dickinson and Company), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 266 |
| 2013 | 0 | — |
| 2014 | 2 | 86 |
| 2015 | 1 | 121 |
| 2016 | 3 | 157 |
| 2017 | 2 | 136 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 28 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Carefusion 2200, Inc. took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| OCV | Endoscope Holder | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 | 1 |
Review panels
- General Hospital (4)
- General and Plastic Surgery (4)
- Cardiovascular (2)
- Gastroenterology and Urology (2)
- Anesthesiology (1)
- Obstetrics and Gynecology (1)
Most recent Carefusion 2200, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 | DXC | 2021-03-04 | 28 |
| K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments | GEI | 2017-05-04 | 133 |
| K162432 | Multi-Link X2 ECG Cable and Lead Wire System | DSA | 2017-01-18 | 140 |
| K160764 | AirLife Autofill Humidification Chamber | BTT | 2016-08-25 | 157 |
| K153554 | Genesis Low Temperature Reusable Rigid Container System | KCT | 2016-03-21 | 98 |
| K151036 | Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments | GCJ | 2016-02-01 | 287 |
| K142529 | Genesis Reusable Rigid Container System | KCT | 2015-01-08 | 121 |
| K140850 | GENESIS REUSABLE RIGID CONTAINER SYSTEM | KCT | 2014-08-27 | 146 |
| K140761 | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA | HES | 2014-04-21 | 26 |
| K113407 | SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS | GEI | 2012-09-07 | 294 |
4 earlier clearances. See the full list in Caduvo.
Recalls
114 product recalls in 17 recall events; 80 initiated in the last five years. Most recent: 2023-07-13.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Carefusion 2200, Inc. (12)
- Carefusion 2200 (2)
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.
- Carefusion Germany 234 GmbH (12 510(k)s)
- Carefusion 303, Inc. (7 510(k)s)
- Carefusion 209, Inc. (5 510(k)s)
- Carefusion, Inc. (3 510(k)s)
- Carefusion (Bd) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carefusion 2200, Inc.?
FDA lists 14 510(k) clearances under 2 spellings of the applicant name “Carefusion 2200, Inc.” (first 2009, latest 2021), across 8 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 Carefusion 2200, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carefusion 2200, Inc. is 127 days. Since 2017: 133 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Carefusion 2200, Inc.?
The most frequent FDA product codes under this applicant name are KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 4); GCJ (Laparoscope, General & Plastic Surgery, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 14 Carefusion 2200, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KCT, Carefusion 2200, 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 (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.