# K052615: Medisize Gold

- Pathway: 510(k) (Traditional)
- Applicant: Medisize BV
- Decided: Dec 9, 2005 after 77 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
1. The Heat and Moisture Exchanger (HME) of the Medisize Gold is intended for passive humidification during anaesthesia and respiratory care. 2. The integrated booster ability makes it possible to feed additional heat and moisture into the system during 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/K052615
Methodology: https://510kreport.com/methodology