510(k) · Cleared
ClearedPuritan-Bennett Companion 550 Liquid Oxygen Portable Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · BYJ Unit, Liquid-Oxygen, Portable
Cleared on Mar 21, 1994 after a 222-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 80 devices in its family, counting itself, have a Class I recall. 79 later devices descend from it.
- Decided
- Mar 21, 1994
- Review
- 222 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 0
79 later devices descend from it, 1 citing it directly. 19 of the 80 devices in this family, counting this one, have a Class I recall.
- This deviceK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- Descendant · cites it directly · 78 of its ownK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- Descendant · 2 generations on · 65 of its ownK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 47 of its ownK062710 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 37 of its ownK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- Descendant · 5 generations on · 21 of its ownK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 79 · See all- K993220Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999 · cites it directly78descendants
- K041122Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · 2 generations on65descendants
- K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 3 generations on47descendants
- K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008 · 4 generations on37descendants
- K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| +1 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| +2 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 1 |
| +3 | K062710 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 2 |
| +4 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| +5 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 1 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 11 | 4 |
| 2012 | 7 | 2 |
| 2013 | 7 | 3 |
| 2014 | 1 | 0 |
| 2015 | 6 | 1 |
| 2016 | 2 | 2 |
| 2017 | 4 | 2 |
| 2018 | 1 | 0 |
| 2019 | 4 | 1 |
| 2020 | 3 | 1 |
| 2021 | 4 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2024 | 2 | 0 |
| 2026 | 2 | 0 |
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
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? (79)
See all 791 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | 1999 | 78 |
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, K993220 (Puritan Bennett Corp., 1999) has gone furthest, with 78 descendants of its own.
How does its category compare?
All BYJ devicesBYJ Unit, Liquid-Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BYJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · BYJ
164in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYJ
4in 2022
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BYJ
1in 2025
MAUDE reports naming product code BYJ, 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 | 2 | — | 1 | 24 |
| 2008 | 3 | 164 | 0 | 33 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 22 |
| 2014 | 0 | — | 0 | 25 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 21 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 4 (4) | 4 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K933930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933930: Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933930
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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