Class Class II

Portable Oxygen Concentrator (Spirit-3) (K242736)

K242736 2025-06-05 Traditional
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Description

Portable Oxygen Concentrator (Spirit-3) by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd., an FDA 510(k) cleared anesthesiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242736
Clearance Date2025-06-05
Clearance TypeTraditional
Product CodeCAW
Regulation Number868.5440

Categories

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Predicate lineage for K242736

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Portable Oxygen Concentrator (Spirit-3) (K242736) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and ...2023
K222086Inogen Rove 4 Portable Oxygen ConcentratorInogen2022

Trace the full predicate network for K242736

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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