# K961455: Medshield/Aerochamber

- Pathway: 510(k) (Traditional)
- Applicant: Diemolding Corp.
- Decided: Jul 25, 1996 after 100 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) Micro Spacer: named in the summary without a submission number
- (no number) AeroChamber: named in the summary without a submission number

## Indications for use
The DHD MedShield is a single-patient-use device. The Intended Use of the device is to reduce the taste effect of Metered Dose Inhaler (MDI) drugs by covering the tongue in the taste sensor area.

Source page: https://510kreport.com/device/K961455
Methodology: https://510kreport.com/methodology