510(k) · Cleared
ClearedStealth Pilot Kit/ Stealth Spacer/Face Mask Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dhd Healthcare Corp. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 18, 1998 as substantially equivalent to K913326 (Dhd Diemolding Healthcare Div., 1992) and 3 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jun 18, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K913326 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK913326 DHD Metered Dose Inhaler (Mdi) SpacerDhd Diemolding Healthcare Div. · 1992
- This deviceK981167 Stealth Pilot Kit/ Stealth Spacer/Face Mask KitDhd Healthcare Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913326 | DHD Metered Dose Inhaler (Mdi) Spacer | Dhd Diemolding Healthcare Div. | 1992 | — |
| 0 (this device) | K981167 | Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit | Dhd Healthcare Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
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What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913326 | DHD Metered Dose Inhaler (Mdi) SpacerSummary page 1…mmon name - MDI Spacer with Facemask Classification name - Spacer - Class Il - 868.5630 Oxygen Mask - Class 1 - 868.5580 Predicate Device: 1- “ACE” MDI Spacer 510(k)’'s K913326A, K953206, K961973 DHD Canastota, NY 13032 2- “Stealth” MDI Spacer 510(k) K973532 DHD Canastota, NY 13032 Device Description: T… | 1992 |
| * | K953206 | DHD Metered Dose Inhaler (Mdi) Spacer (Modification)Summary page 1…- MDI Spacer with Facemask Classification name - Spacer - Class Il - 868.5630 Oxygen Mask - Class 1 - 868.5580 Predicate Device: 1- “ACE” MDI Spacer 510(k)’'s K913326A, K953206, K961973 DHD Canastota, NY 13032 2- “Stealth” MDI Spacer 510(k) K973532 DHD Canastota, NY 13032 Device Description: The Pilot d… | 1995 |
| * | K961973 | DHD Ace with Mask KitSummary page 1…cer with Facemask Classification name - Spacer - Class Il - 868.5630 Oxygen Mask - Class 1 - 868.5580 Predicate Device: 1- “ACE” MDI Spacer 510(k)’'s K913326A, K953206, K961973 DHD Canastota, NY 13032 2- “Stealth” MDI Spacer 510(k) K973532 DHD Canastota, NY 13032 Device Description: The Pilot device is… | 1996 |
| * | K973532 | Stealth, Metered Dose Inhaler (Mdi) Spacer Without Integral ActuatorSummary page 1…5630 Oxygen Mask - Class 1 - 868.5580 Predicate Device: 1- “ACE” MDI Spacer 510(k)’'s K913326A, K953206, K961973 DHD Canastota, NY 13032 2- “Stealth” MDI Spacer 510(k) K973532 DHD Canastota, NY 13032 Device Description: The Pilot device is a mask attachment for the Stealth Metered Dose Inhaler (MDI) Spa… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (210 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981167: Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981167
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026