510(k) · Cleared

Cleared

DK50 DS

K091871510(k) SpecialCleared Oct 23, 2009122-day reviewClass II21 CFR 868.6250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ekom S.R.O. · BTI Compressor, Air, Portable

Cleared on Oct 23, 2009 as substantially equivalent to K060781 (Ekom S.R.O., 2006) and 1 other predicate after a 122-day review. Its family tree reaches back 3 generations to 1987.

Decided: Oct 23, 2009
Review: 122 days
Class: Class II
Product code: BTI
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K864547 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK864547 Bird 6500 Air CompressorBird Products Corp. · 1987
2 generations backK041406 Newport C250 Air Compressor Model C250Newport Medical Instruments · 2004
1 generation backK060781 Medical Compressor, Models DK50 D and DMEkom S.R.O. · 2006
This deviceK091871 DK50 DSEkom S.R.O. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K864547	Bird 6500 Air Compressor	Bird Products Corp.	1987	—
−2	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	—
0 (this device)	K091871	DK50 DS	Ekom S.R.O.	2009	—

FIG. 1 — Lineage of K091871, 1987–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K060781	Medical Compressor, Models DK50 D and DM Summary page 1 …ode: BTI - portable air compressor 21 CFR 868.6250 Device: DK50 DS Predicate Devices: K060781 - Ekom Model DK50 D K041406 - Newport Model C250 Device Description: The Ekomn model DK50 DS i…	Ekom S.R.O.	2006	—
*	K041406	Newport C250 Air Compressor Model C250 Summary page 1 …21 CFR 868.6250 Device: DK50 DS Predicate Devices: K060781 - Ekom Model DK50 D K041406 - Newport Model C250 Device Description: The Ekomn model DK50 DS is a portable air compressor designed to supply air to medical…	Newport Medical Instruments	2004	—

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 22 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All BTI devices

BTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · BTI

1in 2013

2007high 1 (2008) · low 0 (2007)2026

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

2007high 3 (2023) · low 0 (2008)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · BTI

120in 2025

2007high 1,710 (2013) · low 7 (2009)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?

Indicated for supplying compressed air for medical ventilators.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091871 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091871: DK50 DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091871

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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