# Hamilton Medical AG

- Location (FDA's records): Bonaduz, CH
- FDA decisions: 45 (1985–2021): 45 510(k) clearances
- Names in FDA's records: Hamilton Medical AG (30); Hamilton Medical, Inc. (15)
- Product codes: CBK (35), BZR (2), BTT (2), BSK (1), GBX (1), BZD (1), BTI (1), BZO (1)
- 510(k) review time since 2016: median 302 days, against 280 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 82 (36 its own); citations of its devices by later devices: 56 (36 its own)
- Recalls linked to its devices: 35 (14 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Drager, Inc.: 7 (https://510kreport.com/company/drager)
- Maquet Critical Care AB: 6 (https://510kreport.com/company/maquet-critical-care)
- Drager Medical AG & Co. Kgaa: 5 (https://510kreport.com/company/drager-medical-ag-co-kgaa)
- Datex-Ohmeda, Inc.: 4 (https://510kreport.com/company/datex-ohmeda)
- Fisher & Paykel Healthcare, Ltd.: 3 (https://510kreport.com/company/fisher-paykel-healthcare)
- Puritan Bennett Corp.: 3 (https://510kreport.com/company/puritan-bennett)
- Siemens Elema AB: 3 (https://510kreport.com/company/siemens-elema)
- Arm Medical Devices, Inc.: 2 (https://510kreport.com/company/arm-medical-devices)

## Firms that cite its devices most
- Sensor Medics Corp.: 4 (https://510kreport.com/company/sensor-medics)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)
- Nihon Kohden Orangemed, Inc.: 1 (https://510kreport.com/company/nihon-kohden-orangemed)
- Idmed: 1 (https://510kreport.com/company/idmed)
- Aw Technologies Aps: 1 (https://510kreport.com/company/aw-technologies)
- Hamiton Medical AG: 1 (https://510kreport.com/company/hamiton-medical)
- Drager Medical AG & Co. Kgaa: 1 (https://510kreport.com/company/drager-medical-ag-co-kgaa)
- Puritan Bennett Corp.: 1 (https://510kreport.com/company/puritan-bennett)

## Its most-cited devices
- K061090: Galileo Gold Asv (2006), cited by 4
- K150893: IntelliCuff (2016), cited by 4
- K001686: Galileo Ventilator (2000), cited by 4
- K103803: Hamilton-G5 (2011), cited by 3
- K040574: Galileo Gold (2004), cited by 3
- K120670: Hamilton-T1 (2012), cited by 3

## Recent decisions
- K201306: Hamilton-C3 (Feb 5, 2021)
- K201658: Hamilton-C6 (Dec 11, 2020)
- K193228: Hamilton-G5 (May 4, 2020)
- K181216: Hamilton-T1, Hamilton-C1 (Aug 2, 2019)
- K163283: Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010 (Sep 20, 2017)
- K161450: Hamilton-C3 (Apr 27, 2017)
- K153046: Hamilton-MR1 (Sep 6, 2016)
- K152029: Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010 (May 3, 2016)

Source page: https://510kreport.com/company/hamilton-medical