# K091107: Model P8400 Hemostatix Thermal Scalpel System

- Pathway: 510(k) (Traditional)
- Applicant: Hemostatix Medical Technologies, LLC
- Decided: May 1, 2009 after 15 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033089 (2004). 1 ancestor in all.
8 later devices descend from it; 3 cite 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)
- K033089: Hemostatix, Model 2400Z Thermal Scalpel System, Gyrus Ent LLC (2004) Summary page 1.

## Most influential descendants
- K110439: Domain Surgical System (2011), 5 descendants of its own
- K121881: Domain Surgical System (2012), 4 descendants of its own
- K130606: Fmwand Ferromagnetic Surgical System (2014), 3 descendants of its own
- K141484: Open Fmsealer (2014), 1 descendant of its own
- K233185: MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System (2023), 0 descendants of its own

## Recalls of this device
- Jul 27, 2010 · Not classified · Z-2595-2010: Lack of sterility assurance
- Jul 27, 2010 · Not classified · Z-2596-2010: Lack of sterility assurance

## Indications for use
The Model P8400 Hemostatix Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

Source page: https://510kreport.com/device/K091107
Methodology: https://510kreport.com/methodology