# K945531: Blade Electrode

- Pathway: 510(k) (Traditional)
- Applicant: E & M Engineering, Inc.
- Decided: Feb 10, 1995 after 88 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K994075: Geiger Disposable Electrosurgical Electrode, Model 435 (1999), 8 descendants of its own
- K123061: Ace Monopolar Attachment (2013), 7 descendants of its own
- K150029: Habib EUS RFA (2015), 5 descendants of its own
- K181249: EUSRA RF Electrode (2018), 2 descendants of its own
- K240932: HybridTherm System (2024), 1 descendant of its own

Source page: https://510kreport.com/device/K945531
Methodology: https://510kreport.com/methodology