# K990614: Hme-Booster

- Pathway: 510(k) (Traditional)
- Applicant: King Systems Corp.
- Decided: May 23, 2000 after 453 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
The HME-Booster™ makes it possible to feed additional moisture into the system during anesthesia and ventilator care, specifically when the use of an HME alone is no longer adequate due to a patient’s moisture deficit. Only use the Booster T-piece when the Booster heating element is used. The HME-Booster™ can be used with HME's for anesthesia and HME's for ICU, at flow rates between 2L and 12L per minute. The HME-Booster™ has the sole purpose of optimizing the output of the HME. It can only be used at any time in combination with an HME. Not for use with pediatric applications, where tidal volumes are less than or equal to 250 ml and the body weight is less than 20 kg.

Source page: https://510kreport.com/device/K990614
Methodology: https://510kreport.com/methodology