Hamilton Medical AG: FDA filings under this applicant name

FDA lists 30 510(k) clearances under the applicant name “Hamilton Medical AG” (first 2003, latest 2021), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 209 days. Since 2017 the median was 284 days, against 233 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.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Hamilton Medical AG took a median 284 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 233 days.

Top product codes

Review panels

• Anesthesiology (30)

Most recent Hamilton Medical AG 510(k) clearances

20 earlier clearances. See the full list in Caduvo.

Recalls

14 product recalls in 12 recall events; 8 initiated in the last five years. Most recent: 2026-05-29.

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 Hamilton Medical AG is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:

• NCT06655805: Registry for Automated Mechanical VEntilation in Adults (Recruiting, started 2024-09-23)
• NCT01577667: Intellivent Versus Conventional Ventilation (Completed, started 2011-02)

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.

• Hamilton Co. (16 510(k)s)
• Hamilton Medical, Inc. (15 510(k)s)
• Hamilton Industries, Inc. (5 510(k)s)
• Hamilton Thorne Research (5 510(k)s)
• Hamilton Thorne, Inc. (4 510(k)s)
• Hamilton Thorne Biosciences (2 510(k)s)
• Hamilton Thorne Incorporated (2 510(k)s)
• Hamilton Kent (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Hamilton Medical AG?

FDA lists 30 510(k) clearances under the applicant name “Hamilton Medical AG” (first 2003, latest 2021), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Hamilton Medical AG?

The median time from FDA receipt to decision across 510(k)s cleared under the name Hamilton Medical AG is 209 days. Since 2017: 284 days, versus 233 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Hamilton Medical AG?

The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 25); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 2); BSK (Cuff, Tracheal Tube, Inflatable, 1).

Next steps

• See all 30 Hamilton Medical AG clearances with predicates and recalls
• Run predicate analysis for product code CBK, Hamilton Medical AG'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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