# K182610: Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: Dec 19, 2018 after 89 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- 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
Longest line of descent: 11 generations back to K942299 (1995). 89 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080509: Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical Ablation Device, Medtronic, Inc. (2008) Summary page 4.
- K181389: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform, Covidien (2018) Summary page 4.
- K093203: Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841, Medtronic, Inc. (2010) Summary page 5.

## Most influential descendants
- K191601: Valleylab FT10 Electrosurgical Platform (2019), 1 descendant of its own
- K241085: Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) (2024), 0 descendants of its own

## Indications for use
Valleylab FT10 Energy Platform: The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures. Cardioblate BP2 49321 Surgical Ablation Device: The Cardioblate® BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. Cardioblate LP 49341 Surgical Ablation Device: The Cardioblate® LP surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Source page: https://510kreport.com/device/K182610
Methodology: https://510kreport.com/methodology