# K203210: Invacare Platinum 5NXG Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corporation
- Decided: Apr 12, 2021 after 164 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953815 (1995). 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)
- K200890: Invacare Perfecto2V Oxygen Concentrator, Invacare Corporation (2020) Summary page 4.

## Recalls of this device
- Jun 10, 2022 · Class III · Z-1369-2022: Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.

## Indications for use
The Invacare@ Platinum® 5NXG Oxygen Concentrator is indicated for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.

Source page: https://510kreport.com/device/K203210
Methodology: https://510kreport.com/methodology