510(k) · Cleared
ClearedLC Star with Nasal Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pari Innovative Manufacturers, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 2, 2006 as substantially equivalent to K990506 (Mabis Healthcare, Inc., 1999) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.
- Decided
- Jun 2, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963924 (1996). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK963924 LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer…Pari Holding Co. · 1996
- This deviceK061381 LC Star with Nasal AdapterPari Innovative Manufacturers, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK092918 Pari ViosPari Respiratory Equipment, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK191270 Proneb MaxPari Respiratory Equipment, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK131881 Ombra Table Top CompressorTrudell Medical Intl. · 2013
- Descendant · cites it directly · 0 of its ownK092560 Pari SinusPari Respiratory Equipment, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK082541 Healthline Medicator / Redineb Aerosol Drug Delivery SystemMedi Nuclear Corp., Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K092918Pari ViosPari Respiratory Equipment, Inc. · 2010 · cites it directly2descendants
- K191270Proneb MaxPari Respiratory Equipment, Inc. · 2020 · 2 generations on0descendants
- K131881Ombra Table Top CompressorTrudell Medical Intl. · 2013 · 2 generations on0descendants
- K092560Pari SinusPari Respiratory Equipment, Inc. · 2010 · cites it directly0descendants
- K082541Healthline Medicator / Redineb Aerosol Drug Delivery SystemMedi 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 |
|---|---|---|---|---|---|
| −1 | K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70 | Pari Holding Co. | 1996 | — |
| 0 (this device) | K061381 | LC Star with Nasal Adapter | Pari Innovative Manufacturers, Inc. | 2006 | — |
| +1 | K092918 | Pari Vios | Pari Respiratory Equipment, Inc. | 2010 | — |
| +2 | K191270 | Proneb Max | Pari Respiratory Equipment, Inc. | 2020 | — |
| +2 | K131881 | Ombra Table Top Compressor | Trudell Medical Intl. | 2013 | — |
| +1 | K092560 | Pari Sinus | Pari Respiratory Equipment, Inc. | 2010 | — |
| +1 | K082541 | Healthline Medicator / Redineb Aerosol Drug Delivery System | Medi Nuclear Corp., Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K990506 | Mabis NB-02 Ultrasonic NebulizerSummary page 1…Device 510(k) Number MABIS H-ealthcare Mabis NB-02 Ultrasonic Nebulizer K990506 PARt Innovative Manufacturers, Inc. PARI LC® Star Nebulizer K963924 Device Description The LC St… | 1999 |
| * | K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70Summary page 1…Mabis NB-02 Ultrasonic Nebulizer K990506 PARt Innovative Manufacturers, Inc. PARI LC® Star Nebulizer K963924 Device Description The LC Star reusable nebulizer with nasal adapter is a smallI, single patient use, reusable air-powered nebul… | 1996 |
What descends from it? (5)
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?
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 LC Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The nasal adapter facilitates delivery to the upper airways. The LC Star with nasal adapter is intended for adult and pediatric patients consistent with the indications for aerosol medication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061381: LC Star with Nasal Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061381
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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