Drägerwerk: FDA 510(k) clearances across all its applicant names

FDA lists 195 510(k) clearances, 0 PMA and 0 De Novo decisions across the 15 applicant names Caduvo groups under Drägerwerk, first 1977, latest 2026. Median 510(k) review time across these names: 88 days. Since 2017 the median was 230 days, against 195 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 15 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 230 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 195 days.

Top product codes

Plus 33 more product codes.

Review panels

• Anesthesiology (120)
• Cardiovascular (42)
• General Hospital (24)
• General and Plastic Surgery (4)
• Clinical Chemistry (3)
• Physical Medicine (1)
• Clinical Toxicology (1)

Most recent Drägerwerk 510(k) clearances

185 earlier clearances. See the full list in Caduvo.

Recalls

125 product recalls in 65 recall events under these names; 42 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

Dräger entity names (spelled DRAEGER and DRAGER in FDA data), plus Hill-Rom Air-Shields (infant care, acquired by Dräger 2003). Dräger Medical was a joint venture with Siemens 2003–2009.

Sources

• https://en.wikipedia.org/wiki/Dr%C3%A4gerwerk

Frequently asked questions

How many FDA 510(k) clearances are listed across Drägerwerk's applicant names?

FDA lists 195 510(k) clearances, 0 PMA and 0 De Novo decisions across the 15 applicant names Caduvo groups under Drägerwerk, first 1977, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Drägerwerk file under?

The names with the most 510(k) clearances in this group are Draeger Medical, Inc. (82); Draeger Medical Systems, Inc. (49); Drager, Inc. (20); Draeger Medical AG & Co. KG (10); Draegerwerk AG & CO Kgaa (8). The full list of 15 names is on this page.

How long does FDA take to clear Drägerwerk 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 88 days. Since 2017 the median was 230 days, against 195 days for all cleared 510(k)s in the same product codes.

Does the Drägerwerk count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 195 Drägerwerk clearances with predicates and recalls
• Run predicate analysis for product code CBK, Drägerwerk's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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