510(k) · Cleared
ClearedInvacare Tpoc Portable Concentrator, Model TPOC100
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 May 21, 2009 after a 155-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- May 21, 2009
- Review
- 155 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K071902 | FDA’s K071902 is Ams Miniarc Sling System Our reading of the summary gave K071902, FDA’s number for Ams Miniarc Sling System (American Medical Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Invacare Flyer Oxygen Concentrator”. Kept off the family tree. Summary page 1…ame: Oxygen Concentrator Classification Name: Generator, Oxygen, Portable per 21 CFR 868.5440 Legally Marketed Predicate Device(s): Invacare Flyer Oxygen Concentrator; K0719028, Dec 12, 2007. Device Description: The Invacare TPOC is to be used by patients with respiratory disorders who require supplemen… | 2007 |
| † | K020386 | Invacare Platinum, Models Irc 5LX and Irc 5LX02 | 2002 |
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.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 TPOC Portable Oxygen Concentrator 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 TPOC Portable Oxygen Concentrator can be used in a home, institution, vehicle, and various mobile environments. The Invacare TPOC Portable Oxygen Concentrator does not nor is it intended to sustain or support life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083751: Invacare Tpoc Portable Concentrator, Model TPOC100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083751
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026