510(k) · Cleared
ClearedDismounted Medical & Supplemental Oxygen System (Dmos)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Essex Industries, Inc. D/B/A Essex Cryogenics of M · BYJ Unit, Liquid-Oxygen, Portable
Cleared on Jul 19, 2013 as substantially equivalent to K071581 (Essex Cryogenics of Missouri, Inc., 2007) after a 189-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Jul 19, 2013
- Review
- 189 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K880183 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK880183 Portable Therapeutic Liquid Oxygen UnitEssex Cryogenics of Missouri, Inc. · 1988
- 2 generations backK033000 Next Generation Portable Therapeutic Liquid Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2004
- 1 generation backK071581 Backpack Medical Oxygen SystemEssex Cryogenics of Missouri, Inc. · 2007
- This deviceK130068 Dismounted Medical & Supplemental Oxygen System (Dmos)Essex Industries, Inc. D/B/A Essex Cryogenics of M · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K880183 | Portable Therapeutic Liquid Oxygen Unit | Essex Cryogenics of Missouri, Inc. | 1988 | — |
| −2 | 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 | — |
| 0 (this device) | K130068 | Dismounted Medical & Supplemental Oxygen System (Dmos) | Essex Industries, Inc. D/B/A Essex Cryogenics of M | 2013 | — |
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 |
|---|---|---|---|
| * | K071581 | Backpack Medical Oxygen SystemSummary page 1…K130068 3. Substantial Equivalence to Predicate Medical Device The DMOS is substantially equivalent to the Backpack Medical Oxygen System (BMOS) (K07 158 1). 5-1 ~j. Ess, ncd' SQZ C,>R ~eSi LeJi MC 635123 1 3.32337 1… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All BYJ devicesBYJ Unit, Liquid-Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 DMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and/or for delivery to rescue personnel to supplement environmental oxygen at high altitudes while being carried by a rescue personnel at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130068: Dismounted Medical & Supplemental Oxygen System (Dmos).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130068
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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