510(k) · Cleared
ClearedVentilair II Medical Air Compressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Medical AG · BTI Compressor, Air, Portable
Cleared on Mar 14, 2005 as substantially equivalent to K982789 (Drager, Inc., 1998) and 1 other predicate after a 256-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 14, 2005
- Review
- 256 days
- Class
- Class II
- Product code
- BTI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920954 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920954 Air StarInfrasonics Corp. · 1992
- This deviceK041781 Ventilair II Medical Air CompressorHamilton Medical AG · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920954 | Air Star | Infrasonics Corp. | 1992 | — |
| 0 (this device) | K041781 | Ventilair II Medical Air Compressor | Hamilton Medical AG | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (3)
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 |
|---|---|---|---|
| * | K982789 | Medical Air Compressor, Model # 8413419Summary page 2…ties. S. Substanital Eqiuvalence: The Hamilton Medical VENTILAIR II Medical Air Compressor is substantially equivalent to the Draeger Medical Air Compressor (K982789). Infirasonlcs Air Star Portable Compressor (K920954). and the Bennett MC-2 Mobile Air Compresor (Pre- Amendment).… | 1998 |
| * | K920954 | Air StarSummary page 2…VENTILAIR II Medical Air Compressor is substantially equivalent to the Draeger Medical Air Compressor (K982789). Infirasonlcs Air Star Portable Compressor (K920954). and the Bennett MC-2 Mobile Air Compresor (Pre- Amendment). Among the Information presented In the 510(k) submis… | 1992 |
| * | — | Bennett MC-2 Mobile Air Compressor Named without a submission number |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K982789.
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 Hamilton Medical VENTILAIR II is intended for use in hospitals and other institutions as an alternative to central air or cylinder air to supply medical air at 30 psi nominal to the GALILEO and the RAPHAEL models of Hamilton Medical ventilators which are intended to be operated with 30 psi nominal medical air supply. It can also be used as a backup medical air supply for these ventilators in case of failure of their normal air supply.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041781: Ventilair II Medical Air Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041781
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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