510(k) · Cleared
Cleared2300 Series Mgo Portable Oxygen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultra Electronics Limited Precision Air & Land SY · CAW Generator, Oxygen, Portable
Cleared on Apr 25, 2014 as substantially equivalent to K081468 (Sunrise Medical, 2008) and 1 other predicate after a 116-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Apr 25, 2014
- Review
- 116 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933081 (1994). 8 ancestors in all, the oldest K852650 (1985). 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 backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 2 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- 1 generation backK081468 Devilbiss Portable Oxygen Concentrator, 306 SeriesSunrise Medical · 2008
- This deviceK134023 2300 Series Mgo Portable OxygenUltra Electronics Limited Precision Air & Land SY · 2014
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 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −2 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| −1 | K081468 | Devilbiss Portable Oxygen Concentrator, 306 Series | Sunrise Medical | 2008 | — |
| 0 (this device) | K134023 | 2300 Series Mgo Portable Oxygen | Ultra Electronics Limited Precision Air & Land SY | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K081468 | Devilbiss Portable Oxygen Concentrator, 306 SeriesSummary page 3…rade Name iGO Portable Oxygen Generator Model Number 306 Series Contact Name Joseph E. Olsavsky 510(k) Number K081468 The 2300 Series mGO Portable Oxygen Generator is a ruggedized development of the 306 Series IGO Portable Oxygen Generator t… | 2008 |
| * | K083163 | Omni 2 Oxygen SystemSummary page 1…additional predicate device reference added 2 4 1h April 2014 _________________("SAROS 3000, K083163-) _______ Traditional 51 0(k) Submission for the 2300 Series mGO Portable Oxygen Generator (Concentrator), Sec… | 2009 |
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 20 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K081468.
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 2300 Series mGO Portable Oxygen Generator is 1-3 L/min continuous flow (1-6 L/min Pulse Flow), pressure vacuum swing adsorption, supplemental oxygen concentrator, based on molecular sieve technology. The patient typically receives the oxygen through a nasal cannula. The device is not intended for life support, nor does it provide any patient monitoring capabilities. The device is intended for use in environments found in medical facilities, military…
Read the full statement (117 words)
The 2300 Series mGO Portable Oxygen Generator is 1-3 L/min continuous flow (1-6 L/min Pulse Flow), pressure vacuum swing adsorption, supplemental oxygen concentrator, based on molecular sieve technology. The patient typically receives the oxygen through a nasal cannula.
The device is not intended for life support, nor does it provide any patient monitoring capabilities.
The device is intended for use in environments found in medical facilities, military deployment situations or disaster areas for humanitarian relief.
A Physician has prescribed a specific oxygen flow setting to meet an individual's needs. Oxygen flow settings should be adjusted only under the direction of a Physician.
WARNING: Federal Law restricts this device to sale by or on order of a Physician
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134023: 2300 Series Mgo Portable Oxygen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134023
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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