Drägerwerk AG & Co. KGaA: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Drägerwerk AG & Co. KGaA” (first 2022, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 167 days. Since 2017 the median was 167 days, against 204 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 167 |
| 2023 | 1 | 111 |
| 2024 | 0 | — |
| 2025 | 1 | 87 |
| 2026 | 2 | 264 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Drägerwerk AG & Co. KGaA took a median 167 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 204 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| FMZ | Incubator, Neonatal | 1 | 1 |
Review panels
- Anesthesiology (2)
- General Hospital (2)
- Cardiovascular (1)
Most recent Drägerwerk AG & Co. KGaA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | BSZ | 2026-05-21 | 265 |
| K251619 | Babyleo TN500 | FMZ | 2026-02-13 | 262 |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | DSA | 2025-12-01 | 87 |
| K230931 | Atlan | BSZ | 2023-07-23 | 111 |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | CAH | 2022-12-07 | 167 |
Recalls
openFDA lists no recalls under a recalling firm named Drägerwerk AG & Co. KGaA.
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.
Device clinical trials
An industry sponsor named Drägerwerk AG & Co. KGaA is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04489914: Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral Aortic Valve Replacement (Completed, started 2020-10-12)
- NCT03076983: Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time (Completed, started 2017-05-30)
Frequently asked questions
How many FDA 510(k) clearances are listed under Drägerwerk AG & Co. KGaA?
FDA lists 5 510(k) clearances under the applicant name “Drägerwerk AG & Co. KGaA” (first 2022, latest 2026), 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 Drägerwerk AG & Co. KGaA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Drägerwerk AG & Co. KGaA is 167 days. Since 2017: 167 days, versus 204 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Drägerwerk AG & Co. KGaA?
The most frequent FDA product codes under this applicant name are BSZ (Gas-Machine, Anesthesia, 2); CAH (Filter, Bacterial, Breathing-Circuit, 1); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1).
Next steps
- See all 5 Drägerwerk AG & Co. KGaA clearances with predicates and recalls
- Run predicate analysis for product code BSZ, Drägerwerk 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.