# K070714: Medisize Gold Heater and Booster

- Pathway: 510(k) (Traditional)
- Applicant: Medisize BV
- Decided: Apr 30, 2007 after 47 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122885: Medisize Gold Heater and Booster T-Piece (2013), 0 descendants of its own

## Indications for use
The MEDISIZE GOLD Heater and Booster makes it possible to feed additional heat and moisture into the system, through a T-Piece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.

Source page: https://510kreport.com/device/K070714
Methodology: https://510kreport.com/methodology