510(k) · Cleared
Recalled · 2009Aircraft Medical Oxygen Generation System (Amogs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carleton Life Support Systems, Inc. · OLF Medevac Use Oxygen Generator
Cleared on Dec 22, 2008 as substantially equivalent to K020330 (Pacific Consolidated Industries Llp, 2002) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 1994. It has been recalled once.
- Decided
- Dec 22, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- OLF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933081 (1994). 11 ancestors in all, the oldest K904087 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 4 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 3 generations backK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- 2 generations backK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- 1 generation backK020330 Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002
- This deviceK082829 Aircraft Medical Oxygen Generation System (Amogs)Carleton Life Support Systems, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −4 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −3 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| −2 | K014078 | ON Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| −1 | K020330 | Deployable Oxygen Concentration System (Docs) | Pacific Consolidated Industries Llp | 2002 | — |
| 0 (this device) | K082829 | Aircraft Medical Oxygen Generation System (Amogs) | Carleton Life Support Systems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 3 | 0 |
| 2001 | 2 | 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 OLF? 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? (2)
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 |
|---|---|---|---|
| * | K020330 | Deployable Oxygen Concentration System (Docs)Summary page 1…es to which Substantial Equivalence is claimed: Deployable Oxygen Generation System - Medium (DOGS-M) developed by Carleton Life Support Systems, cleared under submittal K020330 and Total 02 manufactured by Chad Therapeutics, cleared under submittal K971889. Description The AMOGS system is designed to pr… | 2002 |
| * | K971889 | Chad Total O2 Delivery SystemSummary page 1…tem - Medium (DOGS-M) developed by Carleton Life Support Systems, cleared under submittal K020330 and Total 02 manufactured by Chad Therapeutics, cleared under submittal K971889. Description The AMOGS system is designed to provide supplemental oxygen meeting USP93% requirements using the Pressure Swing A… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2009 | Not classified | Z-2009-2009 | Device Design | The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 4 other devices also cite its predicate K020330.
How does its category compare?
All OLF devicesOLF Medevac Use Oxygen Generator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OLF
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · OLF
Too few OLF 510(k)s in any year since 2007 to give a median.
Recalls per year · OLF
No recall names OLF since 2007.
Adverse event reports per year · OLF
No MAUDE report names OLF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMOGS system is intended to provide oxygen enriched gas generated by the pressure swing adsorption process to patients who may have difficulty extracting oxygen from air that they breathe while on board the HH-60M MEDEVAC helicopter. The system may be used to provide medical support to the full spectrum of deployed scenarios including wartime operations, deterrence and contingency operations, peacetime engagement, crisis response and humanitarian…
Read the full statement (115 words)
The AMOGS system is intended to provide oxygen enriched gas generated by the pressure swing adsorption process to patients who may have difficulty extracting oxygen from air that they breathe while on board the HH-60M MEDEVAC helicopter. The system may be used to provide medical support to the full spectrum of deployed scenarios including wartime operations, deterrence and contingency operations, peacetime engagement, crisis response and humanitarian relief operations by trained personnel.
The oxygen supplied by the AMOGS is supplemental and is not considered to be life supporting or life sustaining.
This device is not intended to be used in the presence of flammable anesthetics nor is it intended to be sterilized.
There are no contraindications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082829: Aircraft Medical Oxygen Generation System (Amogs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082829
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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