# K040812: Detect Surgical Pacing and Mapping Tool

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Sep 2, 2004 after 157 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012459 (2001). 1 ancestor in all.
20 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012459: Model 6494 Unipolar Temporary Myocardial Pacing Wire, Medtronic Vascular (2001) Summary page 1.

## Most influential descendants
- K051749: Cobra Surgical System (2005), 19 descendants of its own
- K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 (2006), 13 descendants of its own
- K100501: Multifunctional Linear Pen (2010), 9 descendants of its own
- K113475: Estech Cobra Adhere XL 2 Surgical System (2012), 4 descendants of its own
- K130521: Isolator Linear Pen (2013), 3 descendants of its own

## Indications for use
The DETECT TM Surgical Pacing and Mapping Tool is a handheld, single use device designed to provide temporary cardiac pacing or monitoring.

Source page: https://510kreport.com/device/K040812
Methodology: https://510kreport.com/methodology