Draeger Medical AG & Co. KG: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Draeger Medical AG & Co. KG” (first 2008, latest 2010), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 117 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 | 3 | 3 |
| BSZ | Gas-Machine, Anesthesia | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
Review panels
- Anesthesiology (8)
- Cardiovascular (1)
- General Hospital (1)
Most recent Draeger Medical AG & Co. KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102618 | VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED | BTT | 2010-12-10 | 88 |
| K092029 | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 | BYE | 2010-08-06 | 396 |
| K100941 | INFINITY MCABLE - MAINSTREAM CO2 | CCK | 2010-04-23 | 18 |
| K092999 | NBP CUFF | DXQ | 2009-11-24 | 57 |
| K083050 | EVITE XL | CBK | 2008-12-29 | 76 |
| K081447 | FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO | BSZ | 2008-10-08 | 139 |
| K081743 | CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS | CBK | 2008-09-22 | 95 |
| K072884 | FABIUS MRI | BSZ | 2008-07-30 | 295 |
| K072885 | CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 | CBK | 2008-04-07 | 181 |
| K072002 | FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 | CAH | 2008-01-31 | 192 |
Recalls
openFDA lists no recalls under a recalling firm named Draeger Medical AG & Co. KG.
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.
- Draeger Medical, Inc. (82 510(k)s)
- Draeger Medical Systems, Inc. (49 510(k)s)
- Draeger Medical B.V. (2 510(k)s)
- Draeger Medical Infant Care, Inc. (2 510(k)s)
- Draeger Medical Sytems, Inc. (2 510(k)s)
- Draeger Medical AG & Co. Kgaa (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Draeger Medical AG & Co. KG?
FDA lists 10 510(k) clearances under the applicant name “Draeger Medical AG & Co. KG” (first 2008, latest 2010), across 7 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 Draeger Medical AG & Co. KG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Draeger Medical AG & Co. KG is 117 days.
Which FDA product codes appear under Draeger Medical AG & Co. KG?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 3); BSZ (Gas-Machine, Anesthesia, 2); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 1).
Next steps
- See all 10 Draeger Medical AG & Co. KG clearances with predicates and recalls
- Run predicate analysis for product code CBK, Draeger Medical AG & Co. KG'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.