510(k) · Cleared
ClearedPuritan-Bennett Helios Portable Liquid Oxygen System
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 Oct 22, 1999 as substantially equivalent to K933930 (Puritan Bennett Corp., 1994) after a 25-day review. Its family tree reaches back 1 generation to 1994. 19 of the 80 devices in its family, counting itself, have a Class I recall. 78 later devices descend from it.
- Decided
- Oct 22, 1999
- Review
- 25 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933930 (1994). 78 later devices descend from it, 4 citing it directly. 19 of the 80 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- This deviceK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- Descendant · cites it directly · 65 of its ownK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · 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
- Descendant · 3 generations on · 21 of its ownK080181 Modification to Galileo GoldHamilton Medical AG · 2008
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 78 · See all- K041122Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · cites it directly65descendants
- 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
- K080181Modification to Galileo GoldHamilton Medical AG · 2008 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| 0 (this device) | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| +1 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 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 | — |
| +3 | K080181 | Modification to Galileo Gold | Hamilton Medical AG | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitSummary page 1…s per 21 CFR 868.5655 Predicate Device Equivalence Puritan-Bennett is claiming substantial equivalence to the Puritan-Bennett Companion 550 Liquid Oxygen (Lox) System, K933930. Device Description The Helios portable liquid oxygen system consists of a vacuum insulated cryogenic container… | 1994 |
What descends from it? (78)
See all 784 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)
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 · 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, K041122 (Precision Medical, Inc., 2004) has gone furthest, with 65 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 | — |
What is it indicated for?
The Puritan-Bennett Helios Portable Liquid Oxygen System is intended to provide supplemental oxygen to oxygen therapy patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used as an ambulatory source of oxygen both inside and outside the patient’s home. It is not intended as life sustaining or life supporting device. The device has no contraindications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993220: Puritan-Bennett Helios Portable Liquid Oxygen System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993220
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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