# K924521: Disposable Concentric Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Chalgren Enterprises, Inc.
- Decided: Feb 12, 1993 after 157 days
- Product code: IKT (Electrode, Needle, Diagnostic Electromyograph)
- Device class: 2
- Regulation: 21 CFR 890.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K011818: Sterile Emg Electrodes (2001), 1 descendant of its own
- K111131: Teca (TM) Elite Disposable Monopolar Needles (2011), 0 descendants of its own
- K080914: Ultrasharp Concentric Needles (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K924521
Methodology: https://510kreport.com/methodology