510(k) · Cleared
ClearedTRUST
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 Apr 2, 2004 as substantially equivalent to K980407 (B&B Medical Technologies, Inc., 1998) after a 14-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Apr 2, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980407 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK980407 Hope NebulizerB&B Medical Technologies, Inc. · 1998
- This deviceK040718 TRUSTDhd Healthcare Corp. · 2004
- Descendant · cites it directly · 1 of its ownK080230 Neb-U-Mask System, Models 1895, 1896Teleflexmedical, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK130379 Rollins 7 Oxygen MaskRollins Medical Solutions, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980407 | Hope Nebulizer | B&B Medical Technologies, Inc. | 1998 | — |
| 0 (this device) | K040718 | TRUST | Dhd Healthcare Corp. | 2004 | — |
| +1 | K080230 | Neb-U-Mask System, Models 1895, 1896 | Teleflexmedical, Inc. | 2008 | — |
| +2 | K130379 | Rollins 7 Oxygen Mask | Rollins Medical Solutions, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 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
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K980407 | Hope NebulizerSummary page 1…Trade name: To Be Determined Common Name: Nebulizer Classification Name: Nebulizer - 868.5630 Predicate Devices: Hope Nebulizer K980407 B&B Medical Technologies P.O. Box 1958 Loomis, CA 95650 Device Description: The DHD TRUST is indicated for use as a single patie… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080230 | Neb-U-Mask System, Models 1895, 1896 | 2008 | 1 |
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?
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 TRUST is intended for use as a nebulizer.
The DHD TRUST provides additional hydration to help loosen secretions for patients whom extended therapy is required.
The DHD TRUST delivers aerosolized medications and diagnostic formulations.
Patients with asthma, pneumonia, COPD, or any other condition in which appropriate medications would be nebulized.
To be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040718: TRUST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040718
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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