510(k) · Cleared
ClearedOxygen Generator Liquefier - (Ogl)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Essex Cryogenics of Missouri, Inc. · CAW Generator, Oxygen, Portable
Cleared on Feb 21, 2014 as substantially equivalent to K022684 (Essex Cryogenics of Missouri, Inc., 2002) after a 238-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Feb 21, 2014
- Review
- 238 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904087 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK904087 Mobilaire Iii and V Model Irc 301 and 501 Oxy. ConInvacare Corp. · 1990
- 1 generation backK022684 Portable Therapeutic Oxygen Concentration System (Ptocs)Essex Cryogenics of Missouri, Inc. · 2002
- This deviceK131990 Oxygen Generator Liquefier - (Ogl)Essex Cryogenics of Missouri, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904087 | Mobilaire Iii and V Model Irc 301 and 501 Oxy. Con | Invacare Corp. | 1990 | — |
| −1 | K022684 | Portable Therapeutic Oxygen Concentration System (Ptocs) | Essex Cryogenics of Missouri, Inc. | 2002 | — |
| 0 (this device) | K131990 | Oxygen Generator Liquefier - (Ogl) | Essex Cryogenics of Missouri, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 CAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAW device
- #1 K230052 Inogen Rove 6score 29.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K022684 | Portable Therapeutic Oxygen Concentration System (Ptocs)Summary page 1…Oxygen Generator Liquefier- (OGL) Predicate Device: Portable Therapeutic Oxygen Concentrator System (PTOCS) - K022684 Device Description: The OGL is a device that generates 93% UISP oxygen gaseous, liquefy it into LOX and store up to 40 liters of… | 2002 |
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 24 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · CAW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAW
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · CAW
611in 2025
MAUDE reports naming product code CAW, 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 | 6 | 143 | 1 | 23 |
| 2008 | 11 | 90 | 3 | 25 |
| 2009 | 8 | 193 | 2 | 43 |
| 2010 | 5 | 133 | 0 | 48 |
| 2011 | 6 | 174 | 1 | 167 |
| 2012 | 5 | 148 | 0 | 395 |
| 2013 | 2 | — | 2 | 2,309 |
| 2014 | 6 | 277 | 2 | 24,538 |
| 2015 | 1 | — | 0 | 18,973 |
| 2016 | 1 | — | 1 | 3,167 |
| 2017 | 1 | — | 1 | 107 |
| 2018 | 3 | 203 | 0 | 116 |
| 2019 | 2 | — | 2 | 120 |
| 2020 | 5 | 224 | 1 | 125 |
| 2021 | 2 | — | 0 | 194 |
| 2022 | 4 | 458 | 2 | 305 |
| 2023 | 8 | 261 | 0 | 357 |
| 2024 | 2 | — | 5 (1) | 450 |
| 2025 | 12 | 178 | 1 | 611 |
| 2026 | 6 | 260 | 0 | — |
What is it indicated for?
The OGL is intended to be used by emergency response personnel in military and commercial applications to produce emergency source of 93% USP liquid oxygen (LOX) which will be transferred into portable LOX systems. The portable LOX systems are used as an emergency source of supplemental oxygen for patient(s) while being transported for a crisis situation to a health care facility. This medical device is for supplemental oxygen and is not intended to sustain or support life.
Environments of Use: Locations where LOX oxygen generation is desired, e.g. military, hospital.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131990: Oxygen Generator Liquefier - (Ogl).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131990
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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