X-PLO2R

FDA 510(k) K203086 · Belluscura, LLC

Substantially Equivalent

510(k) numberK203086

Submission

Device name
X-PLO2R
Applicant
Belluscura, LLC
Plano, TX, US
Received
October 13, 2020
Decision date
March 2, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CAW – Generator, Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5440
Specialty
Anesthesiology

Other 510(k)s with product code CAW

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K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAW · Traditional BMC Medical Co., Ltd.08/14/2026SE
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K252965Oxygen Concentrator (OX-5A, OX-5C)CAW · Traditional Oxytek Medical Technology Co., Ltd.05/29/2026SE
K252407OxyGo Portable Oxygen Concentrator (1400-7000)CAW · Traditional Mv Life, LLC04/23/2026SE
K253549DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional Devilbiss Healthcare, LLC03/26/2026SE
K251534Oxygen Concentrator (J10A)CAW · Traditional Foshan Kycare Medical Equipment Co., Ltd.12/29/2025SE
K252616Portable oxygen concentrator (JLO-190P)CAW · Traditional Shenzhen Homed Medical Device Co., Ltd.12/22/2025SE
K251764Oxygen Concentrator-P2-O5ECAW · Traditional Qingdao Kingon Medical Science and Technology…12/22/2025SE
K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional Shenzhen Harveymed Technology Co., Ltd.12/16/2025SE
K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional Devilbiss Healthcare, LLC12/09/2025SE

Questions and answers

When was X-PLO2R cleared by the FDA?

X-PLO2R (K203086) received a 510(k) decision of Substantially Equivalent on March 2, 2021, 140 days after the submission was received.

What is the product code of K203086?

The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.