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Hamilton Medical AG: FDA-registered device maker in BONADUZ Graubunden, Switzerland, 6 510(k) clearances

Name: Hamilton Medical AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hamilton Medical AG is registered with the FDA (registration 3001421318) in BONADUZ Graubunden, Switzerland. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 5, 2021. 7 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Hamilton Medical AG

FDA registration number: 3001421318
Address: Via Crusch 8, BONADUZ Graubunden, Switzerland, 7402
Owner or operator: Hamilton Medical AG (10059168)
Roles: Specification developer
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
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	BZE	2	Specification developer	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Specification developer	accessdata.fda.gov
Mixer, Breathing Gases, Anesthesia Inhalation	BZR	2	Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Specification developer	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Specification developer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Specification developer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Specification developer	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
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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 15, 2024	94671	Class I	Ongoing	Ventilator HAMILTON-C6, PN: 160021	Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilatio	accessdata.fda.gov
March 14, 2023	91925	Class II	Ongoing	HAMILTON-C6, REF: 160021	Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator	accessdata.fda.gov
June 27, 2022	90576	Class I	Ongoing	HAMILTON-C6 Intensive Care Ventilator, REF: 160021	Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with	accessdata.fda.gov
January 5, 2021	90460	Class III	Completed	HAMILTON-H900 Humidifier, Models: 950001, 950004	When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.	accessdata.fda.gov
March 25, 2019	82328	Class I	Terminated	HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The	New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.	accessdata.fda.gov
March 12, 2018	78599	Class II	Ongoing	Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.	After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.	accessdata.fda.gov
March 9, 2018	80467	Class II	Terminated	Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the re	An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.	accessdata.fda.gov

Compare with other makers

Updated June 18, 2024. 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.