Salter Labs High Flow Bubble Humidifier
by Salter Labs, Arvin Facility
510(k) K113542
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113542 | Date10 Feb 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Salter Labs Bubble Humidifier (High Flow)
- 510(k) Number
- FDA Product Code
- BTT
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5450
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Respiratory Gas Humidifier, Direct Patient Interface, designed to humidify high-flow supplemental breathing gases. It uses a bubble diffusion mechanism to add moisture to oxygen or other respiratory gases delivered at flow rates of 6–15 LPM, ensuring adequate hydration for patients receiving high-flow therapy.
The Salter Labs High Flow Bubble Humidifier is intended for single-patient use in non-sterile settings, including homecare, hospitals, extended care facilities, and hospice environments. It features a 350cc bubble chamber with 360 molded diffuser ports and a 6 PSI audible pop-off pressure alarm. Supplied in packs of 5, 10, or 25, the device has received FDA 510(k) clearance under the Anesthesiology advisory committee and is classified as a Class II medical device (FDA regulation 868.5450).
Questions
AI-generated answers, 19 Sep 2026
What environments is the Salter Labs High Flow Bubble Humidifier designed for, and how does its single-use nature impact its use in those settings?
The Salter Labs High Flow Bubble Humidifier is designed for use in non-sterile settings such as homecare, hospitals, extended care facilities, and hospice environments. Its single-patient-use designation ensures patient safety by preventing cross-contamination between uses, which is particularly important in shared or high-traffic clinical areas like hospitals and hospice care.
How is the Salter Labs High Flow Bubble Humidifier supplied, and what are the available pack sizes?
The device is supplied in packs containing either 5, 10, or 25 units. This allows for flexibility in ordering based on facility needs, whether for small homecare setups or larger hospitals requiring bulk inventory.
What safety feature does the Salter Labs High Flow Bubble Humidifier include to protect against excessive pressure, and how does this benefit clinical use?
The device includes a 6 PSI audible pop-off pressure alarm, which alerts clinicians to potential overpressure conditions. This feature helps prevent equipment damage or patient discomfort by ensuring the system operates within safe pressure limits during high-flow therapy.
What flow rates does the Salter Labs High Flow Bubble Humidifier support, and how does this range benefit patient care?
The humidifier is designed to operate at flow rates of 6–15 liters per minute (LPM), making it suitable for a wide range of high-flow therapy needs. This range accommodates varying patient requirements, from moderate to high oxygen or respiratory gas delivery, ensuring adequate hydration for patients receiving supplemental breathing support.
How does the bubble diffusion mechanism in the Salter Labs High Flow Bubble Humidifier contribute to its effectiveness in humidifying respiratory gases?
The device uses a 350cc bubble chamber with 360 molded diffuser ports to create fine bubbles, which maximize surface area for moisture exchange with the gas flow. This mechanism ensures efficient and consistent humidification of oxygen or other respiratory gases, reducing the risk of dryness or irritation for patients receiving high-flow therapy.