# K981167: Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dhd Healthcare Corp.
- Decided: Jun 18, 1998 after 78 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 K913326 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913326: DHD Metered Dose Inhaler (Mdi) Spacer, Dhd Diemolding Healthcare Div. (1992) Summary page 1.
- K953206: DHD Metered Dose Inhaler (Mdi) Spacer (Modification), Dhd Diemolding Healthcare Div. (1995) Summary page 1.
- K961973: DHD Ace with Mask Kit, Dhd Diemolding Healthcare Div. (1996) Summary page 1.
- K973532: Stealth, Metered Dose Inhaler (Mdi) Spacer Without Integral Actuator, Dhd Diemolding Healthcare Div. (1998) Summary page 1.

## Indications for use
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). Pilot is a one piece, silicone rubber face mask that may be attached to the Stealth MDI holding chamber as an interface between the Stealth MDI and the patient’s face/mouth region. Use of the Stealth Spacer, without integral actuator, assists with the delivery of aerosolized medications from Metered Dose Inhaler (MDI) canisters. Use of the Stealth Spacer reduces patient coordination and technique oriented problems associated with MDI drug delivery. When used with the Stealth Spacer, the Pilot face mask reduces coordination and technique problems associated with MDI drug delivery in lieu of the Stealth Mouthpiece. Patients capable of following directions for hand held use of Metered Dose Inhaler (MDI) Spacer therapy as determined by a physician. Patients requiring mask interface. Pilot allows a clinical choice for use of the Stealth MDI spacer with a mouthpiece and/or a mask. May be used in hospital as well as the home.

Source page: https://510kreport.com/device/K981167
Methodology: https://510kreport.com/methodology