# K981944: Breatherite

- Pathway: 510(k) (Traditional)
- Applicant: Ventlab Corp.
- Decided: Aug 24, 1998 after 82 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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
VENTLAB Corporation's BreatheRite MDI Spacer is designed to work in conjunction with a metered dose inhaler (MDI) to provide a dispersion chamber that will aid the sufferer in inhaling a suitable asthmatic medication properly. The BreatheRite MDI Spacer consists of a chamber that secures the metered dose inhalers mouthpiece with an elastomeric flange adapter at one end, a chamber connected to a one-way valve adapter, which opens on inhalation, and an exhalation adapter that allows the air to exhaust to the atmosphere both of which are housed within the mouthpiece. Federal (USA) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K981944
Methodology: https://510kreport.com/methodology