510(k) · Cleared
ClearedPari Vios
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pari Respiratory Equipment, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Feb 4, 2010 as substantially equivalent to K061381 (Pari Innovative Manufacturers, Inc., 2006) and 1 other predicate after a 135-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.
- Decided
- Feb 4, 2010
- Review
- 135 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963924 (1996). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK963924 LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer…Pari Holding Co. · 1996
- 1 generation backK061381 LC Star with Nasal AdapterPari Innovative Manufacturers, Inc. · 2006
- This deviceK092918 Pari ViosPari Respiratory Equipment, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK191270 Proneb MaxPari Respiratory Equipment, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK131881 Ombra Table Top CompressorTrudell Medical Intl. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70 | Pari Holding Co. | 1996 | — |
| −1 | K061381 | LC Star with Nasal Adapter | Pari Innovative Manufacturers, Inc. | 2006 | — |
| 0 (this device) | K092918 | Pari Vios | Pari Respiratory Equipment, Inc. | 2010 | — |
| +1 | K191270 | Proneb Max | Pari Respiratory Equipment, Inc. | 2020 | — |
| +1 | K131881 | Ombra Table Top Compressor | Trudell Medical Intl. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K061381 | LC Star with Nasal AdapterSummary page 1…Device 510(k) Number PARI Respiratory Equipment, Inc. Trek S Nebulizer Compressor K(061381 PAR] Respiratory Equipment, Inc. Proneb Ultia K(002862 Device Description The PAPA… | 2006 |
| * | K002862 | Proneb Ultra Model Number 85B0100Summary page 1…t, Inc. Trek S Nebulizer Compressor K(061381 PAR] Respiratory Equipment, Inc. Proneb Ultia K(002862 Device Description The PAPA Vios nebulizer comptessor is a small, lightweight AC-powered air compressor intended to provide a so… | 2001 |
What descends from it? (2)
2 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191270 (Pari Respiratory Equipment, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061381.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092918: Pari Vios.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092918
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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