# K201658: Hamilton-C6

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Dec 11, 2020 after 176 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 5 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K902859 (1991). 122 ancestors in all.
1 later device descends from it; 1 cites it directly.
15 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161450: Hamilton-C3, Hamilton Medical AG (2017) Summary page 4.

## Most influential descendants
- K252663: Inbentus Versatile (2026), 0 descendants of its own

## Recalls of this device
- Jun 3, 2025 · Class I · Z-2328-2025: 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 
- May 15, 2024 · Class I · Z-2020-2024: 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
- Mar 14, 2023 · Class II · Z-1429-2023: 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
- Sep 22, 2022 · Class II · Z-0267-2023: 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.
- Jun 27, 2022 · Class I · Z-1525-2022: 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 venti

## Indications for use
The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates. Intended areas of use: * In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room * During transfer of ventilated patients within the hospital The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

Source page: https://510kreport.com/device/K201658
Methodology: https://510kreport.com/methodology