510(k) · Cleared
ClearedOmbra Table Top Compressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trudell Medical Intl. · BTI Compressor, Air, Portable
Cleared on Oct 24, 2013 as substantially equivalent to K031413 (Vega Technologies, Inc., 2003) and 1 other predicate after a 121-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Oct 24, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- BTI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963924 (1996). 8 ancestors in all, the oldest K914836 (1992). 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 deviceK131881 Ombra Table Top CompressorTrudell Medical Intl. · 2013
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) | K131881 | Ombra Table Top Compressor | Trudell Medical Intl. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 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 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? (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 |
|---|---|---|---|
| * | K031413 | Vigormist Compressor NebulizerSummary page 1…ication Regulation 868.6250 Predicate Device 510(k) Number Tralde/Model Name Manufacturer K031413 Airial MQ5600 Medquip K(092918… | 2003 |
| * | K092918 | Pari ViosSummary page 1…Tralde/Model Name Manufacturer K031413 Airial MQ5600 Medquip K(092918 Pani Vios Compressor Pani Device Description The Omra Table Top Compressor… | 2010 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All BTI devicesBTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Ombra* Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131881: Ombra Table Top Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131881
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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