510(k) · Cleared
Recalled · Class II · 2013Compressor Mini, 115 V, Model 64 81 779 EH81E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Elema AB · BTI Compressor, Air, Portable
Cleared on Sep 5, 2003 as substantially equivalent to K951926 (Allan Rehnstrom AB, 1995) after a 333-day review. Its family tree reaches back 1 generation to 1995. 19 of the 53 devices in its family, counting itself, have a Class I recall. 51 later devices descend from it. It has been recalled once.
- Decided
- Sep 5, 2003
- Review
- 333 days
- Class
- Class II
- Product code
- BTI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951926 (1995). 51 later devices descend from it, 2 citing it directly. 19 of the 53 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK951926 Alreco 40400Allan Rehnstrom AB · 1995
- This deviceK023354 Compressor Mini, 115 V, Model 64 81 779 EH81ESiemens Elema AB · 2003
- Descendant · cites it directly · 49 of its ownK051895 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005
- Descendant · 2 generations on · 48 of its ownK060862 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 47 of its ownK062710 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 37 of its ownK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- Descendant · 4 generations on · 21 of its ownK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 51 · See all- K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005 · cites it directly49descendants
- K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 2 generations on48descendants
- K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 2 generations on47descendants
- K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008 · 3 generations on37descendants
- K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951926 | Alreco 40400 | Allan Rehnstrom AB | 1995 | — |
| 0 (this device) | K023354 | Compressor Mini, 115 V, Model 64 81 779 EH81E | Siemens Elema AB | 2003 | — |
| +1 | K051895 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2005 | — |
| +2 | K060862 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 1 |
| +2 | K062710 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 2 |
| +3 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| +4 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 1 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 4 |
| 2012 | 5 | 2 |
| 2013 | 6 | 3 |
| 2014 | 1 | 0 |
| 2015 | 5 | 1 |
| 2016 | 2 | 2 |
| 2017 | 4 | 2 |
| 2018 | 1 | 0 |
| 2019 | 3 | 1 |
| 2020 | 2 | 1 |
| 2021 | 3 | 1 |
| 2023 | 1 | 1 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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.
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
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 |
|---|---|---|---|
| * | K951926 | Alreco 40400Summary page 1…n: Compressor Mini is a first time application. Substantial equivalence to a predicate device, ALRECO 40400 Allan Rehnstrom AB K95 1926, is claimed. F.4 Device Description: Compressor Mini will provide a supply of dry and filtered compres… | 1995 |
What descends from it? (51)
See all 512 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (19 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2013 | Class II | Z-0848-2014 | Material/Component Contamination | Maquet Compressor Mini may deliver compressed air at a temperature higher than specified. |
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 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 4 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 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 5 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 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 6 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?
- Its one ancestor has no recall.
- Of its descendants, K051895 (Datex-Ohmeda, Inc., 2005) has gone furthest, with 49 descendants 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 intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Ymin at 50-64 psi (350 - 450 H a , 3.5 - 4.5 bar). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is intended to be used for bedside application in a hospital enhonment. Compressor Mini is not intended to be used during in-hospital transportation or during ambulance or air transportation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023354: Compressor Mini, 115 V, Model 64 81 779 EH81E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023354
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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