# K182757: Espire Elbow Pro, Espire Elbow Hybrid

- Pathway: 510(k) (Traditional)
- Applicant: College Park Industries, Inc.
- Decided: Nov 29, 2018 after 62 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: 2 generations back to K032833 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123795: Axon-Bus Prosthetic System, Otto Bock Austria (2014) Summary page 5.

## Indications for use
The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The Espire Elbow processes user’s input signals to activate and control elbow movement.

Source page: https://510kreport.com/device/K182757
Methodology: https://510kreport.com/methodology