510(k) · Cleared
ClearedDevilbiss Portable Oxygen Concentrator, 306 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical · CAW Generator, Oxygen, Portable
Cleared on Aug 25, 2008 as substantially equivalent to K013931 (Sequal Technologies, Inc., 2002) after a 90-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Aug 25, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933081 (1994). 6 ancestors in all, the oldest K852650 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 3 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 2 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 1 generation backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- This deviceK081468 Devilbiss Portable Oxygen Concentrator, 306 SeriesSunrise Medical · 2008
- Descendant · cites it directly · 0 of its ownK172648 Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorDevilbiss Healthcare, LLC · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK134023 2300 Series Mgo Portable OxygenUltra Electronics Limited Precision Air & Land SY · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −3 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −2 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −1 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| 0 (this device) | K081468 | Devilbiss Portable Oxygen Concentrator, 306 Series | Sunrise Medical | 2008 | — |
| +1 | K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | Devilbiss Healthcare, LLC | 2018 | 1 |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K013931 | Omni Oxygen System, Model 1000Summary page 1…21 CFR 868.5440 Predicate Device Name(s) and 510(k) Sequal Eclipse Portable Oxygen number(s): Concentrator- K013931 Section 5.0 Page 1 of 3 Description of Device: The model 306 Series oxygen… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K172648 (Devilbiss Healthcare, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K013931.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Model 306 iGo Portable Oxygen Concentrator System is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081468: Devilbiss Portable Oxygen Concentrator, 306 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081468
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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