# K083751: Invacare Tpoc Portable Concentrator, Model TPOC100

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corporation
- Decided: May 21, 2009 after 155 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K071902: Ams Miniarc Sling System, American Medical Systems, Inc. (2007). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K083751
Methodology: https://510kreport.com/methodology