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Hamilton-C6 160021

by Hamilton Medical AG

Ref 160021

Hamilton-C6 160021 is a neonatal/adult intensive-care ventilator (EU MDR Class IIb; FDA Class II; FDA product code CBK, Ventilator, Continuous, Facility Use) made by Hamilton Medical AG, registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 76300028PN160021ZW), cleared under FDA 510(k) K201658 on 11 Dec 2020 and listed in FDA GUDID since 26 Jan 2022 (UDI-DI 07630002808590), active as of 9 Nov 2026. 5 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201658

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300028PN160021ZW Basic UDI-DI 07630002808590UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630002808590 UDI-DI Date26 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201658 Date11 Dec 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 76300028PN160021ZW registered 2 Sep 2026 Active
  • FDA 510(k) K201658 decided 11 Dec 2020 Active
  • FDA GUDID UDI-DI 07630002808590 listed 26 Jan 2022 Listed

Recalls

5 recalls · 5 ongoing · FDA

    • Ongoing Z-2328-2025 FDA Class I initiated 3 Jun 2025

    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.

    • Ongoing Z-2020-2024 FDA Class I initiated 15 May 2024

    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) Ventilation is not re-initiated by the ventilator.

    • Ongoing Z-1429-2023 FDA Class II initiated 14 Mar 2023

    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 and is operational.

    • Ongoing Z-0267-2023 FDA Class II initiated 22 Sep 2022

    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.

    • Ongoing Z-1525-2022 FDA Class I initiated 27 Jun 2022

    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 Panel connection lost message displayed

Timeline

8 dated events

  1. Cleared FDA 510(k) K201658
  2. Listed FDA GUDID 07630002808590
  3. Recall initiated FDA recalls Z-1525-2022
  4. Recall initiated FDA recalls Z-0267-2023
  5. Recall initiated FDA recalls Z-1429-2023
  6. Recall initiated FDA recalls Z-2020-2024
  7. Recall initiated FDA recalls Z-2328-2025
  8. Registered EUDAMED 76300028PN160021ZW

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Hamilton-C6
Generic name
Neonatal/adult intensive-care ventilator
Model / Ref / Catalog
160021
Primary DI / UDI-DI
07630002808590
Basic UDI-DI
76300028PN160021ZW
510(k) Number
FDA product code
CBK
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Neonatal/adult intensive-care ventilator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5895
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Neonatal/adult intensive-care ventilator

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Hamilton Medical AG

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Properties

  • Administering medicine
  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)