# K093617: Ventlab 6000 Series Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Ventlab Corp.
- Decided: Jan 27, 2011 after 430 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 Ventlab 6000 Series Humidifier is a device intended to add moisture to breathing gases for administration to a patient. Its use is indicated whenever a physician or other healthcare provider prescribes humidification to patients receiving supplemental oxygen via oxygen tubing and nasal cannulae. This device is single patient use, non-sterile prescription device that is indicated in both hospital and homecare applications.

Source page: https://510kreport.com/device/K093617
Methodology: https://510kreport.com/methodology