# K031982: Birdsong Leverhaler, Model LH-1000

- Pathway: 510(k) (Traditional)
- Applicant: Birdsong Medical Devices, Inc.
- Decided: Apr 2, 2004 after 281 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
Longest line of descent: 1 generation back to K911807 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911807: Metered Dose Inhaler (Mdi) Spacer, Health Products, Inc. (1991) Summary page 1.

## Indications for use
The LeverHaler Spacer is a spacer device that is designed to effectively deliver respirable medical aerosols produced by most MDI's to a patient during inhalation. This product is intended for use in the treatment of lung disease. The device has been designed for use by all patients who have been prescribed MDI treatment by their physician. It is intended for use in both the hospital and homecare environments.

Source page: https://510kreport.com/device/K031982
Methodology: https://510kreport.com/methodology