Data / Medical devices / Switzerland / Hamilton Medical AG
Hamilton Medical AG: FDA-registered device maker in Domat / Ems Graubunden, Switzerland, 10 510(k) clearances
Hamilton Medical AG is registered with the FDA (registration 3014766741) in Domat / Ems Graubunden, Switzerland. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 5, 2021. 5 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014766741
- Address
- Parc lndustrial Vial 10, Domat / Ems Graubunden, Switzerland, 7013
- Owner or operator
- Hamilton Medical AG (10059168)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 18, 2019
- Registered through
- 2026
- Brand names listed
- Breathing circuit set, coaxial, single use, adult/pediatric PN 260094, PN 260127, PN 260128, PN 260184, PN 260206, Breathing circuit set, coaxial, single use, adult/pediatric PN 260167, PN 260168, PN 260145, PN 260144, PN 260087, Breathing circuit set, coaxial, single use, adult/pediatric PN 260207, PN 260239, PN 260240, PN 260257, Breathing circuit sets, dual limb, single use, neonatal PN 260180, PN 260182, PN 260169, PN 260170, Breathing circuit sets, dual limb, single use, neonatal/pediatric PN 260241, PN 260244, Expiratory valve set , reusable, PN 161175, PN 161188, PN 151972, PN 160245, Expiratory valve set , single use, PN 160176, PN 161186, PN 161189, PN 950158, Flow sensor, single use, adult/pediatric PN 282051, PN 281637, PN 950185 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Compressor, Air, Portable | BTI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 5, 2021 | K201306 | HAMILTON-C3 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| December 11, 2020 | K201658 | Hamilton-C6 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| May 4, 2020 | K193228 | Hamilton-G5 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| August 2, 2019 | K181216 | HAMILTON-T1, HAMILTON-C1 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| September 20, 2017 | K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| September 6, 2016 | K153046 | HAMILTON-MR1 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| May 3, 2016 | K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| January 29, 2016 | K150893 | IntelliCuff | BSK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| November 16, 2012 | K121225 | HAMILTON-C2 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| March 14, 2005 | K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR | BTI | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 29, 2026 | 99028 | Class I | Ongoing | Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators. | Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to o | accessdata.fda.gov |
| May 22, 2026 | 99035 | Class II | Ongoing | IntelliCuff, Portable automatic cuff pressure controller REF: 951001 | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user. | accessdata.fda.gov |
| June 26, 2025 | 97222 | Class I | Ongoing | Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators. | Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction. | accessdata.fda.gov |
| June 3, 2025 | 97079 | Class I | Ongoing | Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neon | A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation. | accessdata.fda.gov |
| September 22, 2022 | 90916 | Class II | Ongoing | Hamilton-C6 | Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Continuous, Facility Use
- All makers of Tubing, Pressure And Accessories
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Compressor, Air, Portable
- All makers of Oximeter
Updated June 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.