# K854413: Malis Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Valley Forge Scientific Corp.
- Decided: Dec 2, 1985 after 28 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K033499: Malis Irrigation Module 1000 (2003), 2 descendants of its own
- K200169: VFS1 Bipolar Electrosurgical Generator (2020), 0 descendants of its own
- K182801: Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K854413
Methodology: https://510kreport.com/methodology