# K973532: Stealth, Metered Dose Inhaler (Mdi) Spacer Without Integral Actuator

- Pathway: 510(k) (Traditional)
- Applicant: Dhd Diemolding Healthcare Div.
- Decided: Mar 19, 1998 after 182 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.
- (no number) ACE® - Aerosol Cloud Enhancer: named in the summary without a submission number
- (no number) Aerochamber®: named in the summary without a submission number

## Most influential descendants
- K981167: Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit (1998), 0 descendants of its own

## Indications for use
1 - Purpose: The DHD Stealth Metered Dose Inhaler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with their associated actuator elbows. In addition, for convenience, the MDI canister/elbow may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber). 2 - Claims: 2.1 Use of the Stealth Spacer, without integral actuator, assists with the delivery of aerosolized medications from Metered Dose Inhaler (MDI) canisters. 2.2 Use of the Stealth Spacer reduces patient coordination and technique oriented problems associated with MDI drug delivery. 3 - Target Patient Population: Patients capable of following directions for hand held use of Metered Dose Inhaler (MDI) Spacer therapy as determined by a physician. 4 - Intended Environment For Use 4.1 Labeling reflects the statement: “Federal (USA) Law restricts this device to sale by or on the order of a physician.” 4.2 May be used in hospital as well as the home.

Source page: https://510kreport.com/device/K973532
Methodology: https://510kreport.com/methodology