# K111131: Teca (TM) Elite Disposable Monopolar Needles

- Pathway: 510(k) (Special)
- Applicant: Carefusion 209, Inc.
- Decided: Jun 17, 2011 after 57 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
Longest line of descent: 2 generations back to K850107 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011818: Sterile Emg Electrodes, Nicolet Biomedical, Inc. (2001) Summary page 1.

## Indications for use
TECATM1 elite Disposable Monopolar Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMO) and nerve potential signals.

Source page: https://510kreport.com/device/K111131
Methodology: https://510kreport.com/methodology