510(k) Report

510(k) · Cleared

Cleared

Medical Air Compressor

K040220510(k) TraditionalCleared Jun 9, 2004128-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

eVent Medical, Ltd. · BTI Compressor, Air, Portable

Cleared on Jun 9, 2004 as substantially equivalent to K982789 (Drager, Inc., 1998) after a 128-day review. Its family tree reaches back 1 generation to 1998.

Decided
Jun 9, 2004
Review
128 days
Class
Class II
Product code
BTI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K982789 (1998). No later device cites it as a predicate yet.

K982789 · Medical Air Compressor, Model # 8413419 · Drager, Inc. · 1998 · recalled199619982000200220042006
K982789 · Medical Air Compressor, Model # 8413419 · Drager, Inc. · 1998 · recalled0
  1. Root · 1 generation backK982789 Medical Air Compressor, Model # 8413419Drager, Inc. · 1998 · Recalled
  2. This deviceK040220 Medical Air CompressoreVent Medical, Ltd. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K982789Medical Air Compressor, Model # 8413419Drager, Inc.19981
0 (this device)K040220Medical Air CompressoreVent Medical, Ltd.2004—
FIG. 1 — Lineage of K040220, 1998–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K982789Medical Air Compressor, Model # 8413419
Summary page 1
…equivalence to the following predicate medical device: Predicate Device 510(k) Number Classification Drager Inc. Medical Air K982789 Class II, Compressor, Model 98 Portable Air Compressor…
Drager, Inc.19981

Also cleared against K982789: 1 other device →

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?

  • Its one ancestor has a recall.
  • 1 other device also cites its predicate K982789.

How does its category compare?

All BTI devices

BTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTI

1in 2013

2008: 12009: 12012: 12013: 1
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

2007: 12013: 12023: 3, 3 Class I
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

2007: 182008: 92009: 72010: 112011: 132012: 2172013: 1,7102014: 9822015: 2942016: 1392017: 1032018: 712019: 1142020: 1112021: 2782022: 2482023: 3252024: 1662025: 120
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—118
20081—09
20091—07
20100—011
20110—013
20121—0217
20131—11,710
20140—0982
20150—0294
20160—0139
20170—0103
20180—071
20190—0114
20200—0111
20210—0278
20220—0248
20230—3 (3)325
20240—0166
20250—0120
20260—0—

What is it indicated for?

The Independence TM Medical Air Compressor is indicated for use as a Medical Air Compressor providing compressed air to ventilators.

Indications for use as stated in the FDA summary.

Also cleared against K982789

1 other device cites the same predicate.

  • K041781Ventilair II Medical Air CompressorHamilton Medical AG · 2005

More from eVent Medical, Ltd.

5 FDA decisions under this applicant name. See the company

  • K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 20131 Class I recall
  • K051550Inspiration Ventilator SystemeVent Medical, Ltd. · 20051 recall
  • K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd. · 2004
  • K021112Inspiration Ventilator SystemeVent Medical, Ltd. · 2002

Recent decisions in BTI

The BTI category page

  • K131881Ombra Table Top CompressorTrudell Medical Intl. · 2013
  • K113338Medical Air CompressorOricare, Inc. · 2012
  • K091871DK50 DSEkom S.R.O. · 2009
  • K072634Emg Triton -Comp,Model NCA01-XXX SeriesEmg Technology Co., Ltd. · 2008
  • K060781Medical Compressor, Models DK50 D and DMEkom S.R.O. · 2006

https://510kreport.com/device/K040220 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040220: 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/K040220

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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