510(k) · Cleared
ClearedConcentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corporation · CAW Generator, Oxygen, Portable
Cleared on Aug 29, 2019 as substantially equivalent to K160630 (Invacare Corporation, 2016) after a 120-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Aug 29, 2019
- Review
- 120 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020324 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002 · Recalled
- 3 generations backK032818 Inogen One Oxygen ConcentratorInogen, Inc. · 2004 · Recalled
- 2 generations backK071928 The Invacare Flyer, Model Ipc 100Invacare Corp. · 2007
- 1 generation backK160630 Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation · 2016
- This deviceK191159 Concentrator with Single battery pack, carry bag with shoulder…Invacare Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020324 | Lifestyle Oxygen Concentrator | Airsep Corp. | 2002 | 3 |
| −3 | K032818 | Inogen One Oxygen Concentrator | Inogen, Inc. | 2004 | 1 |
| −2 | K071928 | The Invacare Flyer, Model Ipc 100 | Invacare Corp. | 2007 | — |
| −1 | K160630 | Invacare Platinum Mobile Oxygen Concentrator | Invacare Corporation | 2016 | — |
| 0 (this device) | K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back… | Invacare Corporation | 2019 | — |
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 |
|---|---|---|---|
| * | K160630 | Invacare Platinum Mobile Oxygen ConcentratorSummary page 4…21 CFR 868.5440 Regulatory Class: 2 Product Code: CAW PREDICATE DEVICE: Invacare® Platinum® Mobile Oxygen Concentrator (K160630) Patient Population: Adult Patient Only K191159… | 2016 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Invacare® Platinum® Mobile Oxygen Concentrator The Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home. Invacare® Mobile Medical Application Accessory PICCOLO O2 The Invacare® Mobile Medical Application Accessory PICCOLO O2 is intended for use with the Invacare® Platinum Mobile Oxygen…
Read the full statement (96 words)
Invacare® Platinum® Mobile Oxygen Concentrator
The Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home.
Invacare® Mobile Medical Application Accessory PICCOLO O2
The Invacare® Mobile Medical Application Accessory PICCOLO O2 is intended for use with the Invacare® Platinum Mobile Oxygen Concentrator POC1-100C device, to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/servicing purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191159: Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191159
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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