510(k) · Cleared
ClearedNext Generation Portable Therapeutic Liquid Oxygen System
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 Mar 22, 2004 as substantially equivalent to K880183 (Essex Cryogenics of Missouri, Inc., 1988) after a 179-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.
- Decided
- Mar 22, 2004
- Review
- 179 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880183 (1988). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK880183 Portable Therapeutic Liquid Oxygen UnitEssex Cryogenics of Missouri, Inc. · 1988
- This deviceK033000 Next Generation Portable Therapeutic Liquid Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK071581 Backpack Medical Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK130068 Dismounted Medical & Supplemental Oxygen System (Dmos)Essex Industries, Inc. D/B/A Essex Cryogenics of M · 2013
- Descendant · cites it directly · 0 of its ownK113767 Mounted Medical Oxygen SystemEssex Industries, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK101272 Mass Oxygen Distribution System (Mods) Model 10C-0061-3Essex Industries, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K071581Backpack Medical Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2007 · cites it directly1descendant
- K130068Dismounted Medical & Supplemental Oxygen System (Dmos)Essex Industries, Inc. D/B/A Essex Cryogenics of M · 2013 · 2 generations on0descendants
- K113767Mounted Medical Oxygen SystemEssex Industries, Inc. · 2012 · cites it directly0descendants
- K101272Mass Oxygen Distribution System (Mods) Model 10C-0061-3Essex Industries, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880183 | Portable Therapeutic Liquid Oxygen Unit | Essex Cryogenics of Missouri, Inc. | 1988 | — |
| 0 (this device) | K033000 | Next Generation Portable Therapeutic Liquid Oxygen System | Essex Cryogenics of Missouri, Inc. | 2004 | — |
| +1 | K071581 | Backpack Medical Oxygen System | Essex Cryogenics of Missouri, Inc. | 2007 | — |
| +2 | K130068 | Dismounted Medical & Supplemental Oxygen System (Dmos) | Essex Industries, Inc. D/B/A Essex Cryogenics of M | 2013 | — |
| +1 | K113767 | Mounted Medical Oxygen System | Essex Industries, Inc. | 2012 | — |
| +1 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K880183 | Portable Therapeutic Liquid Oxygen UnitSummary page 1…Marketed Device which substantial equivalence is claimed: Portable Therapeutic Liquid Oxygen System (PTLOX) 5 10(k) K880183 Description: The NPTLOX is a portable, thermally insulated container designed to store liquid oxygen (99.9%) and convert the liq… | 1988 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K071581 (Essex Cryogenics of Missouri, Inc., 2007) has gone furthest, with 1 descendant 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 NPTLOX is intended to convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery at 50 psig nominal for military use settings only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033000: Next Generation Portable Therapeutic 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/K033000
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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