510(k) · Cleared
ClearedProneb Ultra Model Number 85B0100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pari Holding Co. · BTI Compressor, Air, Portable
Cleared on Mar 13, 2001 after a 181-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 13, 2001
- Review
- 181 days
- Class
- Class II
- Product code
- BTI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK002862 Proneb Ultra Model Number 85B0100Pari Holding Co. · 2001
- 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 ownK060357 Trek S Nebulizer CompressorPari Innovative Manufacturers, Inc. · 2006
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
- K060357Trek S Nebulizer CompressorPari Innovative Manufacturers, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002862 | Proneb Ultra Model Number 85B0100 | Pari Holding Co. | 2001 | — |
| +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 | K060357 | Trek S Nebulizer Compressor | Pari Innovative Manufacturers, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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?
- Of its descendants, K092918 (Pari Respiratory Equipment, Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BTI devicesBTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTI
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · BTI
Too few BTI 510(k)s in any year since 2007 to give a median.
Recalls per year · BTI
3in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · BTI
120in 2025
MAUDE reports naming product code BTI, 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 | 0 | — | 1 | 18 |
| 2008 | 1 | — | 0 | 9 |
| 2009 | 1 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 217 |
| 2013 | 1 | — | 1 | 1,710 |
| 2014 | 0 | — | 0 | 982 |
| 2015 | 0 | — | 0 | 294 |
| 2016 | 0 | — | 0 | 139 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 0 | — | 0 | 114 |
| 2020 | 0 | — | 0 | 111 |
| 2021 | 0 | — | 0 | 278 |
| 2022 | 0 | — | 0 | 248 |
| 2023 | 0 | — | 3 (3) | 325 |
| 2024 | 0 | — | 0 | 166 |
| 2025 | 0 | — | 0 | 120 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K002862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002862: Proneb Ultra Model Number 85B0100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002862
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026