510(k) · Cleared
ClearedNeb-90 Large Volume Medication Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi Nuclear Corp., Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 30, 2008 as substantially equivalent to K915075 (Medi Nuclear Corp., Inc., 1992) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jun 30, 2008
- Review
- 115 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915075 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915075 Nebulizer (Direct Patient Interface)Medi Nuclear Corp., Inc. · 1992
- This deviceK080657 Neb-90 Large Volume Medication NebulizerMedi Nuclear Corp., Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915075 | Nebulizer (Direct Patient Interface) | Medi Nuclear Corp., Inc. | 1992 | — |
| 0 (this device) | K080657 | Neb-90 Large Volume Medication Nebulizer | Medi Nuclear Corp., Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 13.3 · 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? (3)
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 |
|---|---|---|---|
| * | K915075 | Nebulizer (Direct Patient Interface)Summary page 1…edication Nebulizer (LVN), Hereinafter referred to as "Neb-90" 3. PREDICATE DEVICE: Medi/Nuclear Neb-3A Patient Nebulizer (K915075) Smiths Medical - DHD Health Flo-Mist [B&B Medical Technologies Inc. Hope Nebulizer (K980407]… | 1992 |
| * | K980407 | Hope NebulizerSummary page 1…PREDICATE DEVICE: Medi/Nuclear Neb-3A Patient Nebulizer (K915075) Smiths Medical - DHD Health Flo-Mist [B&B Medical Technologies Inc. Hope Nebulizer (K980407] Page 3 of 39 Neb-90 Submission 510(k) Premarket Notification (K08… | 1998 |
| * | — | Smiths Medical - DHD Health Flo-Mist Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K915075.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Neb-90TM Large Volume Medication Nebulizer is indicated for the continuous aerosol administration of respiratory medication (inhalable solution) including, but not necessarily limited to, beta adrenergic bronchodilator (albuterol sulfate) and/or a wetting agent such as sodium chloride solution (saline) that is used for the treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis.
The Neb-90TM Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080657 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080657: Neb-90 Large Volume Medication Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080657
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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