Carefusion 209, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Carefusion 209, Inc.” (first 2011, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. 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 | 2 | 132 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 2 | 2 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 2 | 2 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
Review panels
- Neurology (5)
Most recent Carefusion 209, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120979 | CAREFUSION NICOLET EDX | GWF | 2012-04-25 | 23 |
| K112052 | CAREFUSION NICOLET EDX | GWF | 2012-03-15 | 241 |
| K112034 | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES | IKT | 2011-08-12 | 28 |
| K111131 | TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES | IKT | 2011-06-17 | 57 |
| K103140 | NICOLET WIRELESS EEG | GWL | 2011-04-08 | 165 |
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2011-12-16.
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.
- Carefusion 2200, Inc. (14 510(k)s)
- Carefusion Germany 234 GmbH (12 510(k)s)
- Carefusion 303, Inc. (7 510(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 209, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Carefusion 209, Inc.” (first 2011, latest 2012), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Carefusion 209, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carefusion 209, Inc. is 57 days.
Which FDA product codes appear under Carefusion 209, Inc.?
The most frequent FDA product codes under this applicant name are GWF (Stimulator, Electrical, Evoked Response, 2); IKT (Electrode, Needle, Diagnostic Electromyograph, 2); GWL (Amplifier, Physiological Signal, 1).
Next steps
- See all 5 Carefusion 209, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWF, Carefusion 209, 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.