510(k) · Cleared
Recalled · Class II · 2021DHD Ace with Mask Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dhd Diemolding Healthcare Div. · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 15, 1996 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 15, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- CAF
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK961973 DHD Ace with Mask KitDhd Diemolding Healthcare Div. · 1996
- Descendant · cites it directly · 0 of its ownK981167 Stealth Pilot Kit/ Stealth Spacer/Face Mask KitDhd Healthcare Corp. · 1998
Most influential descendants
Showing 1 of 1 · See all- K981167Stealth Pilot Kit/ Stealth Spacer/Face Mask KitDhd Healthcare Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961973 | DHD Ace with Mask Kit | Dhd Diemolding Healthcare Div. | 1996 | — |
| +1 | K981167 | Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit | Dhd Healthcare Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981167 | Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2021 | Class II | Z-1516-2021 | Process control | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981167 (Dhd Healthcare Corp., 1998) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K961973 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961973: DHD Ace with Mask Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961973
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026