# K000032: Leveen Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Radiotherapeutics Corp.
- Decided: Mar 30, 2000 after 85 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K092009: Modification to: Leveen Superslim Needle Electrodes, Models M001262260, M001262270, M001262280, M001262290 (2009), 1 descendant of its own
- K113090: Leveen Superslim Needle Electrode (2012), 0 descendants of its own

## Recalls of this device
- Sep 17, 2012 · Class II · Z-0079-2013: Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-K
- Jul 6, 2009 · Not classified · Z-1876-2009: The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.
- Jul 6, 2009 · Not classified · Z-1877-2009: The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.

Source page: https://510kreport.com/device/K000032
Methodology: https://510kreport.com/methodology