Drager Medizintechnik GmbH: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Drager Medizintechnik GmbH” (first 1999, latest 2003), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 98 days. 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 Drägerwerk, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 5 | 5 |
| FMZ | Incubator, Neonatal | 1 | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 | 1 |
| FTD | Lamp, Surgical | 1 | 1 |
Review panels
Most recent Drager Medizintechnik GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023289 | OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 | CBK | 2003-01-15 | 105 |
| K010793 | OXYLOG 1000, MODEL 2M86840 | CBK | 2001-12-20 | 279 |
| K012177 | VENTVIEW, MODEL 8414095 | CBK | 2001-09-04 | 54 |
| K003068 | SAVINA | CBK | 2001-06-25 | 266 |
| K010093 | NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 | CBK | 2001-06-14 | 154 |
| K010724 | SOLA 700,SOLA 500, SOLA 300 | FTD | 2001-06-07 | 87 |
| K003067 | CALEO | FMZ | 2000-12-13 | 72 |
| K984611 | DRAGER SOLA SERIES, MODELS 1000/700/500/300 | FSY | 1999-03-29 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Drager Medizintechnik 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.
- Drager, Inc. (20 510(k)s)
- Drager Medical AG & Co. Kgaa (3 510(k)s)
- Drager Medical GmbH (1 510(k)s)
- Drager Medical B.V. (1 510(k)s)
- Drager Safety (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Drager Medizintechnik GmbH?
FDA lists 8 510(k) clearances under the applicant name “Drager Medizintechnik GmbH” (first 1999, latest 2003), across 4 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 Drager Medizintechnik GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Drager Medizintechnik GmbH is 98 days.
Which FDA product codes appear under Drager Medizintechnik GmbH?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 5); FMZ (Incubator, Neonatal, 1); FSY (Light, Surgical, Ceiling Mounted, 1).
Next steps
- See all 8 Drager Medizintechnik GmbH clearances with predicates and recalls
- Run predicate analysis for product code CBK, Drager Medizintechnik 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.