# K112034: Teca Elite Disposable Concentric Needles

- Pathway: 510(k) (Special)
- Applicant: Carefusion 209, Inc.
- Decided: Aug 12, 2011 after 28 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: 1 generation back to K961013 (1996). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961013: Disposable Needle Electrode, Medelec Intl. Corp. (1996) Summary page 1.

## Most influential descendants
- K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, (2013), 3 descendants of its own
- K241045: Disposable Subdermal Needle Electrode, Corkscrew (2024), 0 descendants of its own
- K161566: DMS Disposable Subdermal Needle Electrodes (2016), 0 descendants of its own
- K152984: Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (2016), 0 descendants of its own
- K143433: Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm (2015), 0 descendants of its own

## Indications for use
TECATM ELITE Disposable Concentric 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/K112034
Methodology: https://510kreport.com/methodology