# K020386: Invacare Platinum, Models Irc 5LX and Irc 5LX02

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Jul 2, 2002 after 146 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953815 (1995). 2 ancestors in all.
12 later devices descend from it; 5 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991722: Devilbiss 5 Liter Oxygen Concentrator, Sunrise Medical Hhg, Inc. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K990711: Codan Chemospike, Codan US Corp. (1999). Our reading of the summary gave K990711, FDA’s number for Codan Chemospike (Codan US Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sunrise Medical Model DeVilbiss 5 Liter Oxygen Concentrator”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K033405: Longfei Lfy-I-5 Oxygen Concentrator (2005), 5 descendants of its own
- K090007: Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 (2009), 4 descendants of its own
- K230969: Oxygen Concentrator (2023), 3 descendants of its own
- K061426: Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 (2006), 2 descendants of its own
- K200890: Invacare Perfecto2V Oxygen Concentrator (2020), 1 descendant of its own

## Recalls of this device
- Oct 31, 2014 · Class II · Z-0872-2015: The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.
- Sep 23, 2014 · Class II · Z-0577-2015: It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen co

## Indications for use
The intended function and use of the Invacare Model Platinum oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life-

Source page: https://510kreport.com/device/K020386
Methodology: https://510kreport.com/methodology