# K152029: Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: May 3, 2016 after 286 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913368 (1992). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913368: Models MR700/MR720/MR730 Dual Servo Resp Humid Acc, Fisher & Paykel Electronics, Ltd. (1992) Summary page 5.
- K983112: Respiratory Humidifier, Model # MR850, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 5.
- K122432: Adult Evaqua 2' Dual Heated Breathing Circuits, Fisher & Paykel Healthcare, Ltd. (2012) Summary page 5.
- K103767: Dual Heated Infant Vreathing Cirouits, Fisher & Paykel Healthcare, Ltd. (2012) Summary page 5.

## Most influential descendants
- K163283: Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010 (2017), 0 descendants of its own

## Indications for use
The HAMILTON-H900 humidifier is intended to add moisture and to warm breathing gases during invasive and non-invasive mechanical ventilation. The intended area of use is the intensive care ward or the recovery room. The HAMILTON-H900 humidifier 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 for patients > 10 kg. The HAMILTON-BC8022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg. The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg. The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg. The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg.

Source page: https://510kreport.com/device/K152029
Methodology: https://510kreport.com/methodology