510(k) · Cleared
ClearedPortable Therapeutic Liquid Oxygen Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Essex Cryogenics of Missouri, Inc. · BYJ Unit, Liquid-Oxygen, Portable
Cleared on Apr 14, 1988 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 14, 1988
- Review
- 90 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK880183 Portable Therapeutic Liquid Oxygen UnitEssex Cryogenics of Missouri, Inc. · 1988
- Descendant · cites it directly · 4 of its ownK033000 Next Generation Portable Therapeutic Liquid Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK071581 Backpack Medical Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK130068 Dismounted Medical & Supplemental Oxygen System (Dmos)Essex Industries, Inc. D/B/A Essex Cryogenics of M · 2013
- Descendant · 2 generations on · 0 of its ownK113767 Mounted Medical Oxygen SystemEssex Industries, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK101272 Mass Oxygen Distribution System (Mods) Model 10C-0061-3Essex Industries, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K033000Next Generation Portable Therapeutic Liquid Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2004 · cites it directly4descendants
- K071581Backpack Medical Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2007 · 2 generations on1descendant
- K130068Dismounted Medical & Supplemental Oxygen System (Dmos)Essex Industries, Inc. D/B/A Essex Cryogenics of M · 2013 · 3 generations on0descendants
- K113767Mounted Medical Oxygen SystemEssex Industries, Inc. · 2012 · 2 generations on0descendants
- K101272Mass Oxygen Distribution System (Mods) Model 10C-0061-3Essex Industries, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880183 | Portable Therapeutic Liquid Oxygen Unit | Essex Cryogenics of Missouri, Inc. | 1988 | — |
| +1 | K033000 | Next Generation Portable Therapeutic Liquid Oxygen System | Essex Cryogenics of Missouri, Inc. | 2004 | — |
| +2 | K071581 | Backpack Medical Oxygen System | Essex Cryogenics of Missouri, Inc. | 2007 | — |
| +3 | K130068 | Dismounted Medical & Supplemental Oxygen System (Dmos) | Essex Industries, Inc. D/B/A Essex Cryogenics of M | 2013 | — |
| +2 | K113767 | Mounted Medical Oxygen System | Essex Industries, Inc. | 2012 | — |
| +2 | K101272 | Mass Oxygen Distribution System (Mods) Model 10C-0061-3 | Essex Industries, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 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.
Planning a device in BYJ? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033000 | Next Generation Portable Therapeutic Liquid Oxygen System | 2004 | 4 |
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?
- Of its descendants, K033000 (Essex Cryogenics of Missouri, Inc., 2004) has gone furthest, with 4 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/K880183 · printed Nov 4, 2026
Cite this page
510(k) Report. “K880183: Portable Therapeutic Liquid Oxygen Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880183
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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