510(k) · Cleared
ClearedLC Sprint Nebulizer
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 Mar 2, 2006 as substantially equivalent to K023602 (Allegiance Healthcare Corporation, 2003) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Mar 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. 3 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 deviceK060399 LC Sprint NebulizerPari Innovative Manufacturers, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK092560 Pari SinusPari Respiratory Equipment, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK090730 Akita JetActivaero America, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK062158 LC Sprint StarPari Innovative Manufacturers, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See allView 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) | K060399 | LC Sprint Nebulizer | Pari Innovative Manufacturers, Inc. | 2006 | — |
| +1 | K092560 | Pari Sinus | Pari Respiratory Equipment, Inc. | 2010 | — |
| +1 | K090730 | Akita Jet | Activaero America, Inc. | 2009 | — |
| +1 | K062158 | LC Sprint Star | Pari Innovative Manufacturers, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K023602 | Small Volume NebulizerSummary page 1…Device 510(k) Number Allegiance Hlealthcare Corporation Airlife t Misty Max I0 TN1 Nebulizer K023602 PARI Innovative Manufacturers., Inc. PAMI LC'~Star Nebulizer K963924 lDevice Descriptio… | 2003 |
| * | K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70Summary page 1…Airlife t Misty Max I0 TN1 Nebulizer K023602 PARI Innovative Manufacturers., Inc. PAMI LC'~Star Nebulizer K963924 lDevice Description The L-C Sprint is a small, single patient use, reusable air-powered nebUlizer for the inhalation treatment o… | 1996 |
What descends from it? (3)
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 Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint is intended for adult and pediatric patients consistent with the indications for the aerosol medication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060399: LC Sprint Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060399
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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