Draeger Medical Systems, Inc.: FDA filings under this applicant name

FDA lists 49 510(k) clearances under the applicant name “Draeger Medical Systems, Inc.” (first 2003, latest 2026), across 15 product codes in 4 review panels. Median 510(k) review time under this name: 92 days. Since 2017 the median was 181 days, against 188 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Draeger Medical Systems, Inc. took a median 181 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.

Top product codes

Plus 5 more product codes.

Review panels

• Cardiovascular (35)
• General Hospital (7)
• Anesthesiology (6)
• Clinical Chemistry (1)

Most recent Draeger Medical Systems, Inc. 510(k) clearances

39 earlier clearances. See the full list in Caduvo.

Recalls

21 product recalls in 16 recall events; 6 initiated in the last five years. Most recent: 2025-01-14.

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 Draeger Medical Systems, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT02774434: Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age (Completed, started 2016-11)

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 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 Systems, Inc.?

FDA lists 49 510(k) clearances under the applicant name “Draeger Medical Systems, Inc.” (first 2003, latest 2026), across 15 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 Systems, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Draeger Medical Systems, Inc. is 92 days. Since 2017: 181 days, versus 188 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Draeger Medical Systems, Inc.?

The most frequent FDA product codes under this applicant name are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 25); MSX (System, Network And Communication, Physiological Monitors, 5); DQA (Oximeter, 3).

Next steps

• See all 49 Draeger Medical Systems, Inc. clearances with predicates and recalls
• Run predicate analysis for product code MHX, Draeger Medical Systems, 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.

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