# K080914: Ultrasharp Concentric Needles

- Pathway: 510(k) (Abbreviated)
- Applicant: Rochester Electro Medical, Inc.
- Decided: Jul 15, 2008 after 105 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 K896370 (1989). 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)
- K895460: Concentric Electrode Type #13R01, 13R02, Dantec Electronics, Inc. (1990) Summary page 1.
- K931966: Dantec Disposable Concentric Needle, Dantec Medical, Inc. (1994) Summary page 1.
- K924521: Disposable Concentric Needle Electrode, Chalgren Enterprises, Inc. (1993) Summary page 1.
- K896370: Disp. Concentric Needle Electrode (DCP-30, DCP-45), Chalgren Enterprises, Inc. (1989) Summary page 1.
- K933795: Concentric Emg Needle Electrode, Cadwell Laboratories, Inc. (1994) Summary page 1.
- K973529: Neuroline, Disposable Concentric Needle Electrodes, Medicotest A/S (1997) Summary page 1.
- K960591: RE-Usable Bipolar Concentric Needle (237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP, Chalgren Enterprises, Inc. (1996) Summary page 1.

## Indications for use
Recording muscle activity for Electromyography (EMG) applications. For single patient use only. Patient population: Adults.

Source page: https://510kreport.com/device/K080914
Methodology: https://510kreport.com/methodology