# K120853: Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300 System Kit, Right, Small Ness L300 System Kit,

- Pathway: 510(k) (Special)
- Applicant: Bioness, Inc.
- Decided: Apr 20, 2012 after 30 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K122784: Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000; Small Ness L300 System Kit, Right (2012), 10 descendants of its own
- K162407: L300 Go System (2017), 9 descendants of its own
- K173682: L300 Go System (2018), 7 descendants of its own
- K190285: L300 Go System (2019), 5 descendants of its own
- K213622: Cionic Neural Sleeve NS-100 (2022), 2 descendants of its own

Source page: https://510kreport.com/device/K120853
Methodology: https://510kreport.com/methodology