# K091055: Rhythmlink Disposable Concentric Emg Needle, Model D039032252R

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Jun 23, 2009 after 71 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

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

Source page: https://510kreport.com/device/K091055
Methodology: https://510kreport.com/methodology