Draegerwerk AG & CO Kgaa: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Draegerwerk AG & CO Kgaa” (first 2010, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 264 days. Since 2017 the median was 268 days, against 259 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 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 | 1 | 259 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 4 | 302 |
| 2024 | 0 | — |
| 2025 | 1 | 203 |
| 2026 | 1 | 168 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Draegerwerk AG & CO Kgaa took a median 268 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 259 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 4 | 4 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| FMZ | Incubator, Neonatal | 1 | 1 |
Review panels
- Anesthesiology (7)
- General Hospital (1)
Most recent Draegerwerk AG & CO Kgaa 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | CBK | 2026-05-07 | 168 |
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | BTL | 2025-04-04 | 203 |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | BZE | 2023-06-14 | 268 |
| K222207 | Babylog VN800, Babylog VN600 | CBK | 2023-05-16 | 295 |
| K222024 | Evita V800, Evita V600 | CBK | 2023-05-16 | 309 |
| K221118 | CO2 Mainstream Sensor | CCK | 2023-04-05 | 352 |
| K162821 | Babyleo TN500 | FMZ | 2017-06-23 | 259 |
| K093633 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE | CBK | 2010-03-30 | 127 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-11-17.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Draegerwerk AG & CO Kgaa?
FDA lists 8 510(k) clearances under the applicant name “Draegerwerk AG & CO Kgaa” (first 2010, latest 2026), across 5 product codes in 2 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 Draegerwerk AG & CO Kgaa?
The median time from FDA receipt to decision across 510(k)s cleared under the name Draegerwerk AG & CO Kgaa is 264 days. Since 2017: 268 days, versus 259 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Draegerwerk AG & CO Kgaa?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 4); BTL (Ventilator, Emergency, Powered (Resuscitator), 1); BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, 1).
Next steps
- See all 8 Draegerwerk AG & CO Kgaa clearances with predicates and recalls
- Run predicate analysis for product code CBK, Draegerwerk AG & CO Kgaa'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.