Draeger Medical, Inc.: FDA filings under this applicant name
FDA lists 82 510(k) clearances under the applicant name “Draeger Medical, Inc.” (first 1977, latest 2014), across 22 product codes in 4 review panels. Median 510(k) review time under this name: 70 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 | 1 | 532 |
| 2013 | 1 | 234 |
| 2014 | 2 | 476 |
| 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 35 | 35 |
| CBK | Ventilator, Continuous, Facility Use | 9 | 9 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 7 | 7 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 5 | 5 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 3 | 3 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| CBN | Apparatus, Gas-Scavenging | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| BYR | Transducer, Gas Pressure, Differential | 1 | 1 |
Plus 12 more product codes.
Review panels
Most recent Draeger Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121886 | SAVINA 300 SAVINA 300, COUNTRY VARIANTS | CBK | 2014-08-08 | 771 |
| K133886 | PERSEUS A500 | BSZ | 2014-06-20 | 182 |
| K121999 | GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE | FLL | 2013-02-28 | 234 |
| K103035 | SMARTPILOT VIEW MODEL MK04500 | BSZ | 2012-03-28 | 532 |
| K042607 | PRIMUS US | BSZ | 2004-11-26 | 63 |
| K042419 | FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM | BSZ | 2004-10-08 | 31 |
| K042276 | D-VAPOR | CAD | 2004-09-23 | 31 |
| K042086 | FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | BSZ | 2004-08-31 | 28 |
| K041622 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | BSZ | 2004-07-08 | 22 |
| K040847 | MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR | CCK | 2004-06-17 | 77 |
72 earlier clearances. See the full list in Caduvo.
Recalls
103 product recalls in 48 recall events; 35 initiated in the last five years. Most recent: 2024-10-15.
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 Systems, Inc. (49 510(k)s)
- Draeger Medical AG & Co. KG (10 510(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, Inc.?
FDA lists 82 510(k) clearances under the applicant name “Draeger Medical, Inc.” (first 1977, latest 2014), across 22 product codes in 4 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Draeger Medical, Inc. is 70 days.
Which FDA product codes appear under Draeger Medical, Inc.?
The most frequent FDA product codes under this applicant name are BSZ (Gas-Machine, Anesthesia, 35); CBK (Ventilator, Continuous, Facility Use, 9); CAD (Vaporizer, Anesthesia, Non-Heated, 7).
Next steps
- See all 82 Draeger Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSZ, Draeger Medical, Inc.'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.