# 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

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corporation
- Decided: Aug 29, 2019 after 120 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
Longest line of descent: 4 generations back to K020324 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160630: Invacare Platinum Mobile Oxygen Concentrator, Invacare Corporation (2016) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K191159
Methodology: https://510kreport.com/methodology