# K200890: Invacare Perfecto2V Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corporation
- Decided: Aug 6, 2020 after 125 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: 3 generations back to K953815 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020386: Invacare Platinum, Models Irc 5LX and Irc 5LX02, Invacare Corp. (2002) Summary page 4.

## Most influential descendants
- K203210: Invacare Platinum 5NXG Oxygen Concentrator (2021), 0 descendants of its own

## Recalls of this device
- Oct 30, 2020 · Class II · Z-0514-2021: Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fi

## Indications for use
The Invacare® Perfecto.™V 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/K200890
Methodology: https://510kreport.com/methodology