510(k) · Cleared
ClearedBackpack Medical 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 Jul 11, 2007 as substantially equivalent to K033000 (Essex Cryogenics of Missouri, Inc., 2004) after a 33-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Jul 11, 2007
- Review
- 33 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K880183 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK880183 Portable Therapeutic Liquid Oxygen UnitEssex Cryogenics of Missouri, Inc. · 1988
- 1 generation backK033000 Next Generation Portable Therapeutic Liquid Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2004
- This deviceK071581 Backpack Medical Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK130068 Dismounted Medical & Supplemental Oxygen System (Dmos)Essex Industries, Inc. D/B/A Essex Cryogenics of M · 2013
Most influential descendants
Showing 1 of 1 · See all- K130068Dismounted Medical & Supplemental Oxygen System (Dmos)Essex Industries, Inc. D/B/A Essex Cryogenics of M · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K071581 | Backpack Medical Oxygen System | Essex Cryogenics of Missouri, Inc. | 2007 | — |
| +1 | K130068 | Dismounted Medical & Supplemental Oxygen System (Dmos) | Essex Industries, Inc. D/B/A Essex Cryogenics of M | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K033000 | Next Generation Portable Therapeutic Liquid Oxygen SystemSummary page 1…bstantial Equivalence is claimed: Next Generation Portable Therapeutic Liquid Oxygen Converter (NPTLOX) 2004 - 510(k) K033000 Description: The BMOS is a portable thermally insulated container that provides, when filled with liquid oxygen (LOX), an unint… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130068 | Dismounted Medical & Supplemental Oxygen System (Dmos) | 2013 | 0 |
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?
- The line of descent spans 19 years and passes through 1 company; a new generation was cleared every 15.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130068 (Essex Industries, Inc. D/B/A Essex Cryogenics of M, 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K033000.
How does its category compare?
All BYJ devicesBYJ Unit, Liquid-Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 BMOS is intended to be used by emergency response personnel in military and commercial fields to provide an emergency source of supplemental oxygen for patient/s while being transported from a crisis situation to a health care facility. The BMOS is not intended to be a life sustaining or a life-supporting device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071581: Backpack Medical 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/K071581
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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