# K081521: Modification to Hamilton-G5

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Sep 25, 2008 after 118 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K902859 (1991). 54 ancestors in all.
16 later devices descend from it; 2 cite it directly.
13 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070513: Hamilton-G5, Hamilton Medical AG (2007) Summary page 1.
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E, Maquet Critical Care AB (2004) Summary page 1.
- K062093: Avea Ventilator, Viasys Respiratory Care, Inc. (2006) Summary page 1.
- K062710: GE Datex-Ohmeda Engstrom Carestation, Datex-Ohmeda, Inc. (2006) Summary page 1.
- K051263: Evitaxl with Option Smartcare, Drager Medical AG & Co. Kgaa (2005) Summary page 1.
- K983219: Neoflow Option Model Numbers 8413563, 8411900, Drager, Inc. (1998) Summary page 1.

## Most influential descendants
- K102775: Hamilton-C2 (2011), 14 descendants of its own
- K112006: Hamilton-TC1 (2012), 13 descendants of its own
- K120670: Hamilton-T1 (2012), 11 descendants of its own
- K121225: Hamilton-C2 (2012), 8 descendants of its own
- K123637: Hamilton-C3 (2012), 4 descendants of its own

## Recalls of this device
- Mar 25, 2019 · Class I · Z-1874-2019: 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 patien
- Feb 16, 2011 · Not classified · Z-1928-2011: The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operato

## Indications for use
The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment.

Source page: https://510kreport.com/device/K081521
Methodology: https://510kreport.com/methodology