# K262654: Dexus Prosthetic System (MSL2, MSR2)

- Pathway: 510(k) (Special)
- Applicant: Zhejiang Qiangnao Technology Co.,Ltd
- Decided: Aug 27, 2026 after 28 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032833 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220002: Dexus Prosthetics System (Model: MSL1, MSR1), Zhejiang Qiangnao Technology Co.,Ltd (2022) Summary page 6.

## Indications for use
The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.

Source page: https://510kreport.com/device/K262654
Methodology: https://510kreport.com/methodology