# K122885: Medisize Gold Heater and Booster T-Piece

- Pathway: 510(k) (Traditional)
- Applicant: Medisize BV
- Decided: Aug 29, 2013 after 343 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: 1 generation back to K070714 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070714: Medisize Gold Heater and Booster, Medisize BV (2007) Summary page 2.

## Indications for use
The MEDISIZE GOLD Heater and Booster T-Piece is intended to feed additional heat and moisture into the system, through the 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/K122885
Methodology: https://510kreport.com/methodology