510(k) · Cleared
ClearedMedical Compressor, Models DK50 D and DM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekom S.R.O. · BTI Compressor, Air, Portable
Cleared on Oct 3, 2006 as substantially equivalent to K041406 (Newport Medical Instruments, 2004) after a 195-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Oct 3, 2006
- Review
- 195 days
- Class
- Class II
- Product code
- BTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864547 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK864547 Bird 6500 Air CompressorBird Products Corp. · 1987
- 1 generation backK041406 Newport C250 Air Compressor Model C250Newport Medical Instruments · 2004
- This deviceK060781 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 1 of 1 · See all- K091871DK50 DSEkom S.R.O. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864547 | Bird 6500 Air Compressor | Bird Products Corp. | 1987 | — |
| −1 | K041406 | Newport C250 Air Compressor Model C250 | Newport Medical Instruments | 2004 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K041406 | Newport C250 Air Compressor Model C250Summary page 2…essors are substantially equivalent in intended use, physical characteristics, performance, and safety characteristics to the Newport C250 Air Compressor, cleared under #K041406. H. Device Testing Comprehensive testing has been conducted on The DK50 D and DK50 DM Medical Compressors in accordance wit… | 2004 |
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 |
|---|---|---|---|
| K091871 | DK50 DS | 2009 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091871 (Ekom S.R.O., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K041406.
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 DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060781 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060781: Medical Compressor, Models DK50 D and DM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060781
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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