Carefusion Germany 234 GmbH: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Carefusion Germany 234 GmbH” (first 2010, latest 2016), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 154 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 | 3 | 139 |
| 2013 | 0 | — |
| 2014 | 2 | 204 |
| 2015 | 2 | 149 |
| 2016 | 1 | 270 |
| 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 4 | 4 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 3 | 3 |
| BZC | Calculator, Pulmonary Function Data | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
Review panels
- Anesthesiology (10)
- Cardiovascular (1)
- General Hospital (1)
Most recent Carefusion Germany 234 GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153654 | Sentry WEB SmartInterp | DQK | 2016-09-16 | 270 |
| K150810 | Vyntus / SentrySuite Product Line | BZC | 2015-08-14 | 141 |
| K142959 | Vyntus Walk | DQA | 2015-03-20 | 157 |
| K141936 | MICROBLAB, MICROLOOP | BZG | 2014-12-29 | 165 |
| K133925 | VYNTUS/ SENTRYSUITE PRODUCT LINE | BZC | 2014-08-22 | 242 |
| K122699 | SENTRYSUITE PRODUCT LINE | BTY | 2012-11-19 | 76 |
| K113813 | SENTRYSUITE PRODUCT LINE | BTY | 2012-05-10 | 139 |
| K113096 | MICRO I | BZG | 2012-04-13 | 177 |
| K111408 | MICROGARD II | CAH | 2011-10-17 | 151 |
| K111053 | SENTRYSUITE PRODUCT LINE | BTY | 2011-08-12 | 119 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Carefusion Germany 234 GmbH.
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 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 Germany 234 GmbH?
FDA lists 12 510(k) clearances under the applicant name “Carefusion Germany 234 GmbH” (first 2010, latest 2016), across 6 product codes in 3 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 Germany 234 GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carefusion Germany 234 GmbH is 154 days.
Which FDA product codes appear under Carefusion Germany 234 GmbH?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 4); BTY (Calculator, Predicted Values, Pulmonary Function, 3); BZC (Calculator, Pulmonary Function Data, 2).
Next steps
- See all 12 Carefusion Germany 234 GmbH clearances with predicates and recalls
- Run predicate analysis for product code BZG, Carefusion Germany 234 GmbH'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.