# K182112: Sense System with IBT Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Infinite Biomedical Technologies, LLC
- Decided: Oct 5, 2018 after 60 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162891: Complete Control System, Coapt, LLC (2017) Summary page 4.

## Most influential descendants
- K191179: Myo Plus (2019), 1 descendant of its own
- K253256: myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) (2026), 0 descendants of its own

## Indications for use
Sense System with IBT Electrodes is to be used exclusively for external prosthetic fittings of upper limbs.

Source page: https://510kreport.com/device/K182112
Methodology: https://510kreport.com/methodology