# K203086: X-PLO2R

- Pathway: 510(k) (Traditional)
- Applicant: Belluscura, LLC
- Decided: Mar 2, 2021 after 140 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K222086: Inogen Rove 4 Portable Oxygen Concentrator (2022), 10 descendants of its own
- K230052: Inogen Rove 6 (2023), 8 descendants of its own
- K254289: Portable Oxygen Concentrator (OX-1A-E, OX-1B) (2026), 0 descendants of its own
- K260171: Portable Oxygen Concentrator (PO1 5B, PO1 6B) (2026), 0 descendants of its own
- K252399: Portable Oxygen Concentrator (2026), 0 descendants of its own

## Indications for use
The X-PLO2R is a transportable, software-monitored device designed to be used by patients as a portable oxygen delivery system requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in home, institutional, and travel/ mobile environments.

Source page: https://510kreport.com/device/K203086
Methodology: https://510kreport.com/methodology