510(k) · Cleared
ClearedThe Invacare Flyer, Model Ipc 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · CAW Generator, Oxygen, Portable
Cleared on Dec 12, 2007 as substantially equivalent to K032818 (Inogen, Inc., 2004) after a 153-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it.
- Decided
- Dec 12, 2007
- Review
- 153 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020324 (2002). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002 · Recalled
- 1 generation backK032818 Inogen One Oxygen ConcentratorInogen, Inc. · 2004 · Recalled
- This deviceK071928 The Invacare Flyer, Model Ipc 100Invacare Corp. · 2007
- Descendant · cites it directly · 1 of its ownK160630 Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK191159 Concentrator with Single battery pack, carry bag with shoulder…Invacare Corporation · 2019
- Descendant · cites it directly · 0 of its ownK103563 Precision Portable Oxygen Concentration Model 4150Precision Medical, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K160630Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation · 2016 · cites it directly1descendant
- K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder…Invacare Corporation · 2019 · 2 generations on0descendants
- K103563Precision Portable Oxygen Concentration Model 4150Precision Medical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020324 | Lifestyle Oxygen Concentrator | Airsep Corp. | 2002 | 3 |
| −1 | K032818 | Inogen One Oxygen Concentrator | Inogen, Inc. | 2004 | 1 |
| 0 (this device) | K071928 | The Invacare Flyer, Model Ipc 100 | Invacare Corp. | 2007 | — |
| +1 | K160630 | Invacare Platinum Mobile Oxygen Concentrator | Invacare Corporation | 2016 | — |
| +2 | K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back… | Invacare Corporation | 2019 | — |
| +1 | K103563 | Precision Portable Oxygen Concentration Model 4150 | Precision Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K032818 | Inogen One Oxygen ConcentratorSummary page 1…on Name: Oxygen Concentrator Classification Name: Generator, Oxygen, Portable per 21 CFR 868.5440 Legally Marketed Predicate Device(s): Inogen One Oxygen Concentrator; K0328 18, May 13, 2004 Device Description: The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxy… | 2004 |
What descends from it? (3)
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 5 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K160630 (Invacare Corporation, 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K032818.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Invacare Flyer (Model XPOI00) is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071928: The Invacare Flyer, Model Ipc 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071928
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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