510(k) Report

510(k) · Cleared

Cleared

Alreco 40400

K951926510(k) TraditionalCleared Dec 8, 1995227-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

Allan Rehnstrom AB · BTI Compressor, Air, Portable

Cleared on Dec 8, 1995 after a 227-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 19 of the 53 devices in its family, counting itself, have a Class I recall. 52 later devices descend from it.

Decided
Dec 8, 1995
Review
227 days
Class
Class II
Product code
BTI
Recalls
None
Predicates
0

52 later devices descend from it, 1 citing it directly. 19 of the 53 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2003: 1 descendant cleared2005: 2 descendants cleared2006: 2 descendants cleared2008: 3 descendants cleared, 1 with a Class I recall12011: 5 descendants cleared, 4 with a Class I recall42009: 1 descendant cleared2010: 1 descendant cleared2012: 5 descendants cleared, 2 with a Class I recall22013: 6 descendants cleared, 3 with a Class I recall32015: 5 descendants cleared, 1 with a Class I recall12017: 4 descendants cleared, 2 with a Class I recall22019: 3 descendants cleared, 1 with a Class I recall12014: 1 descendant cleared2016: 2 descendants cleared, 2 with a Class I recall22021: 3 descendants cleared, 1 with a Class I recall12020: 2 descendants cleared, 1 with a Class I recall12018: 1 descendant cleared2024: 2 descendants cleared2026: 2 descendants cleared2023: 1 descendant cleared, 1 with a Class I recall11995200020052010201520202025
  1. This deviceK951926 Alreco 40400Allan Rehnstrom AB · 1995
  2. Descendant · cites it directly · 51 of its ownK023354 Compressor Mini, 115 V, Model 64 81 779 EH81ESiemens Elema AB · 2003 · Recalled
  3. Descendant · 2 generations on · 49 of its ownK051895 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005
  4. Descendant · 3 generations on · 48 of its ownK060862 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
  5. Descendant · 3 generations on · 47 of its ownK062710 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
  6. Descendant · 4 generations on · 37 of its ownK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2003: 12005: 22006: 22008: 32009: 12010: 12011: 52012: 52013: 62014: 12015: 52016: 22017: 42018: 12019: 32020: 22021: 32023: 12024: 22026: 2
2003high 6 (2013) · low 0 (2004)2026

Class I recalls in this family

  • K081521 Modification to Hamilton-G54 generations on · 2008
  • K103803 Hamilton-G55 generations on · 2011
  • K111116 Engstrom Carestation, Engstrom Pro, Models…6 generations on · 2011
  • K112722 GE Datex-Ohmeda Avance6 generations on · 2011

Most influential descendants

Showing 5 of 52 · See all
  • K023354Compressor Mini, 115 V, Model 64 81 779 EH81ESiemens Elema AB · 2003 · cites it directly51descendants
  • K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005 · 2 generations on49descendants
  • K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 3 generations on48descendants
  • K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 3 generations on47descendants
  • K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008 · 4 generations on37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951926Alreco 40400Allan Rehnstrom AB1995—
+1K023354Compressor Mini, 115 V, Model 64 81 779 EH81ESiemens Elema AB20031
+2K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2005—
+3K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.20061
+3K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.20062
+4K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200520
200620
200831
200910
201010
201154
201252
201363
201410
201551
201622
201742
201810
201931
202021
202131
202311
202420
202620
FIG. 1 — Lineage of K951926, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

19 devices in this family have a Class I recall. 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (52)

See all 52

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023354Compressor Mini, 115 V, Model 64 81 779 EH81ESiemens Elema AB200351

Has anything in its family been recalled? (19 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
  • K103803Hamilton-G5Hamilton Medical AG · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
  • K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
  • K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
  • K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
  • K121225Hamilton-C2Hamilton Medical AG · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K131774Hamilton-G5Hamilton Medical AG · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
  • K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900…Datex-Ohmeda, Inc. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
  • K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 7 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
  • K120670Hamilton-T1Hamilton Medical AG · 2012 · 7 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls

Nearest 12 of 19 shown.

Nearest 5 of 19; all are on the web page.

What does this lineage say?

  • Of its descendants, K023354 (Siemens Elema AB, 2003) has gone furthest, with 51 descendants of its own.

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—

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/K951926 · printed Nov 5, 2026

Cite this page

510(k) Report. “K951926: Alreco 40400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951926

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026