510(k) · Cleared
Recalled · Class II · 2015Vigormist Compressor Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vega Technologies, Inc. · BTI Compressor, Air, Portable
Cleared on Oct 7, 2003 as substantially equivalent to K914836 (Omron Healthcare, Inc., 1992) and 1 other predicate after a 155-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 7, 2003
- Review
- 155 days
- Class
- Class II
- Product code
- BTI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914836 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K131881Ombra Table Top CompressorTrudell Medical Intl. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914836 | Omron Compressor Nebulizer- Model NE-C09 | Omron Healthcare, Inc. | 1992 | — |
| 0 (this device) | K031413 | Vigormist Compressor Nebulizer | Vega Technologies, Inc. | 2003 | — |
| +1 | K131881 | Ombra Table Top Compressor | Trudell Medical Intl. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K914836 | Omron Compressor Nebulizer- Model NE-C09Summary page 1…icationName: Nebulizer (Direct patient interface) Regulation Number: 21 CFR, 868.5630 3. PREDICATE DEVICE 0 OMRON Compressor Nebulizer (K914836) VEGA Ultrasonic Nebulizer (k00283 1) Vega Technologies Inc. Tradition 510(k) September 14,2003 CONFIDENTI… | 1992 |
| * | K002831 | Vega Ultrasonic NebulizerSummary page 1…face) Regulation Number: 21 CFR, 868.5630 3. PREDICATE DEVICE 0 OMRON Compressor Nebulizer (K914836) VEGA Ultrasonic Nebulizer (k00283 1) Vega Technologies Inc. Tradition 510(k) September 14,2003 CONFIDENTIAL Vigormist Compressor Nebulizer… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131881 | Ombra Table Top Compressor | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2015 | Class II | Z-1720-2015 | Use error | Roscoe Medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the nebulizer. These warnings are to better inform end users of proper care when using… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The VigorMist Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the WestMed VixOne) to convert certain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031413: Vigormist Compressor Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031413
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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