510(k) · Cleared
ClearedProneb Max
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 Jan 23, 2020 as substantially equivalent to K092918 (Pari Respiratory Equipment, Inc., 2010) after a 255-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jan 23, 2020
- Review
- 255 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963924 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK963924 LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer…Pari Holding Co. · 1996
- 2 generations backK061381 LC Star with Nasal AdapterPari Innovative Manufacturers, Inc. · 2006
- 1 generation backK092918 Pari ViosPari Respiratory Equipment, Inc. · 2010
- This deviceK191270 Proneb MaxPari Respiratory Equipment, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70 | Pari Holding Co. | 1996 | — |
| −2 | K061381 | LC Star with Nasal Adapter | Pari Innovative Manufacturers, Inc. | 2006 | — |
| −1 | K092918 | Pari Vios | Pari Respiratory Equipment, Inc. | 2010 | — |
| 0 (this device) | K191270 | Proneb Max | Pari Respiratory Equipment, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 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? (1)
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 |
|---|---|---|---|
| * | K092918 | Pari ViosSummary page 4…CAF There are no other variants or model numbers of this device. 3. Legally Marketed Predicate Device a. Primary Predicate Device PARI Vios, K092918, Product Code CAF b. Reference Device Proneb Ultra, K002862, Product Code BTI 4. Device Description The… | 2010 |
| † | K002862 | Proneb Ultra Model Number 85B0100 | 2001 |
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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K092918.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Proneb Max is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients 2 years and older, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191270: Proneb Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191270
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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