510(k) · Cleared
ClearedMabis NB-02 Ultrasonic Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mabis Healthcare, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Mar 11, 1999 after a 22-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Mar 11, 1999
- Review
- 22 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK990506 Mabis NB-02 Ultrasonic NebulizerMabis Healthcare, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK061381 LC Star with Nasal AdapterPari Innovative Manufacturers, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK092918 Pari ViosPari Respiratory Equipment, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK191270 Proneb MaxPari Respiratory Equipment, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK131881 Ombra Table Top CompressorTrudell Medical Intl. · 2013
- Descendant · 2 generations on · 0 of its ownK092560 Pari SinusPari Respiratory Equipment, Inc. · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K061381LC Star with Nasal AdapterPari Innovative Manufacturers, Inc. · 2006 · cites it directly5descendants
- K092918Pari ViosPari Respiratory Equipment, Inc. · 2010 · 2 generations on2descendants
- K191270Proneb MaxPari Respiratory Equipment, Inc. · 2020 · 3 generations on0descendants
- K131881Ombra Table Top CompressorTrudell Medical Intl. · 2013 · 3 generations on0descendants
- K092560Pari SinusPari Respiratory Equipment, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990506 | Mabis NB-02 Ultrasonic Nebulizer | Mabis Healthcare, Inc. | 1999 | — |
| +1 | K061381 | LC Star with Nasal Adapter | Pari Innovative Manufacturers, Inc. | 2006 | — |
| +2 | K092918 | Pari Vios | Pari Respiratory Equipment, Inc. | 2010 | — |
| +3 | K191270 | Proneb Max | Pari Respiratory Equipment, Inc. | 2020 | — |
| +3 | K131881 | Ombra Table Top Compressor | Trudell Medical Intl. | 2013 | — |
| +2 | K092560 | Pari Sinus | Pari Respiratory Equipment, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2020 | 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? (8)
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, K061381 (Pari Innovative Manufacturers, Inc., 2006) has gone furthest, with 5 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?
The MABIS NB-02 is an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The MABIS NB-02 nebulizer is not intended for use with Pentamidine. It is intended for single patient use.
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/K990506 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990506: Mabis NB-02 Ultrasonic Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990506
Report an extraction error
Are you the manufacturer?
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