510(k) · Cleared
ClearedHope Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B&B Medical Technologies, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on May 27, 1998 after a 113-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- May 27, 1998
- Review
- 113 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK980407 Hope NebulizerB&B Medical Technologies, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK040718 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
- Descendant · cites it directly · 0 of its ownK080657 Neb-90 Large Volume Medication NebulizerMedi Nuclear Corp., Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K040718TRUSTDhd Healthcare Corp. · 2004 · cites it directly2descendants
- K080230Neb-U-Mask System, Models 1895, 1896Teleflexmedical, Inc. · 2008 · cites it directly1descendant
- K130379Rollins 7 Oxygen MaskRollins Medical Solutions, Inc. · 2013 · 2 generations on0descendants
- K080657Neb-90 Large Volume Medication NebulizerMedi Nuclear Corp., Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980407 | Hope Nebulizer | B&B Medical Technologies, Inc. | 1998 | — |
| +1 | 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 | — |
| +1 | K080657 | Neb-90 Large Volume Medication Nebulizer | Medi Nuclear Corp., Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K040718 (Dhd Healthcare Corp., 2004) has gone furthest, with 2 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 | — |
What is it indicated for?
qnig device is to be used under medical supervision in hospitals nusring homes, extended care facilities and outpatient clinics. The HOPE nebulizer is a high output nebulizer to be used tc deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions fcr patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized.
The hope requires 50 psig source gas. He, air or oxygen may be added via Multi-gas inlet.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980407: Hope Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980407
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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