# K040439: Mdi Trigger Guard

- Pathway: 510(k) (Traditional)
- Applicant: North American Technical Services (Nats) Corp.
- Decided: Jul 8, 2004 after 140 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
The MDI Trigger Guard serves as a mechanical stop intended to be used with FDA approved metered dose inhalers. The MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation. Intended for use by entire patient population for which metered dose inhalers are approved, excluding children under the age of 8. Device is not reusable. Device is to be used for the life of the metered dose inhaler, then discarded

Source page: https://510kreport.com/device/K040439
Methodology: https://510kreport.com/methodology