510(k) · Cleared
ClearedNewport C250 Air Compressor Model C250
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newport Medical Instruments · BTI Compressor, Air, Portable
Cleared on Dec 15, 2004 as substantially equivalent to K864547 (Bird Products Corp., 1987) after a 203-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.
- Decided
- Dec 15, 2004
- Review
- 203 days
- Class
- Class II
- Product code
- BTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864547 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK864547 Bird 6500 Air CompressorBird Products Corp. · 1987
- This deviceK041406 Newport C250 Air Compressor Model C250Newport Medical Instruments · 2004
- Descendant · cites it directly · 1 of its ownK060781 Medical Compressor, Models DK50 D and DMEkom S.R.O. · 2006
- Descendant · cites it directly · 0 of its ownK091871 DK50 DSEkom S.R.O. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864547 | Bird 6500 Air Compressor | Bird Products Corp. | 1987 | — |
| 0 (this device) | K041406 | Newport C250 Air Compressor Model C250 | Newport Medical Instruments | 2004 | — |
| +1 | K060781 | Medical Compressor, Models DK50 D and DM | Ekom S.R.O. | 2006 | — |
| +1 | K091871 | DK50 DS | Ekom S.R.O. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K864547 | Bird 6500 Air CompressorSummary page 2…or is substantially equivalent in intended use, physical characteristics, performance, and safety characteristics to the Bird 6500 Air Compressor, cleared under #K864547; the Newport C100 Air Compressor and the Newport C200D Air Compressor. Both the Newport C100 and C200D Air Compressors ar… | 1987 |
| * | — | Newport C100 Air Compressor Named without a submission number | |
| * | — | Newport C200D Air Compressor Named without a submission number |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K060781 (Ekom S.R.O., 2006) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The Newport C250 Air Compressor is designed and manufactured to supply a source of clean, oil-free pressurized air at 42 psig for use with the E100M, El50, E200, and e500 Newport Ventilators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041406: Newport C250 Air Compressor Model C250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041406
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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