Drager, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Drager, Inc.” (first 1991, latest 1999), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 210 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 | 13 | 13 |
| FMT | Warmer, Infant Radiant | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| FMZ | Incubator, Neonatal | 1 | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
Review panels
- Anesthesiology (15)
- General Hospital (4)
- Physical Medicine (1)
Most recent Drager, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992608 | ATC OPTION FOR EVITA 2 DURA AND EVITA 4 | CBK | 1999-08-24 | 20 |
| K984577 | DRAGER OXYLOG 2000 | CBK | 1999-01-22 | 30 |
| K983219 | NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 | CBK | 1998-12-07 | 84 |
| K982789 | MEDICAL AIR COMPRESSOR, MODEL # 8413419 | BTI | 1998-10-29 | 80 |
| K980642 | EVITA 4 (8411900) | CBK | 1998-09-04 | 197 |
| K974176 | BABYLOG 8000 PLUS | CBK | 1998-06-17 | 223 |
| K971198 | BABYTHERM 8004 BABYTHERM 8010 | FMT | 1997-10-03 | 186 |
| K970165 | EVITA 2 DURA | CBK | 1997-08-26 | 222 |
| K954204 | DRAGER INCUBATOR 8000 IC | FMZ | 1997-04-25 | 597 |
| K961687 | EVITA 4 | CBK | 1996-12-13 | 226 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Drager, Inc..
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 Medizintechnik GmbH (8 510(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, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Drager, Inc.” (first 1991, latest 1999), 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 Drager, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Drager, Inc. is 210 days.
Which FDA product codes appear under Drager, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 13); FMT (Warmer, Infant Radiant, 2); BTI (Compressor, Air, Portable, 1).
Next steps
- See all 20 Drager, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Drager, 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.