# K961894: Mdi Tutor

- Pathway: 510(k) (Traditional)
- Applicant: Mdi Tutor, Inc.
- Decided: Aug 14, 1996 after 90 days
- Product code: CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer))
- Device class: 1
- Regulation: 21 CFR 868.5640
- 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. The FDA summary names its predicate without a number.
- (no number) AeroChamber: named in the summary without a submission number
- (no number) InspirEase: named in the summary without a submission number

## Indications for use
The MDI Tutor is intended for use as an accessory to metered dose inhalers (MDISs) to assist the user by monitoring the inhalation cycle and providing positive feedback (an auditory whistle) to corroborate correct inspiratory technique.

Source page: https://510kreport.com/device/K961894
Methodology: https://510kreport.com/methodology