# K140972: Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead, Unipolar Temporary Myocardial Pacing

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jun 6, 2014 after 51 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 K012454 (2001). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012454: Model 6491 Unipolar Pediatric Temporary Pacing Lead, Medtronic Vascular (2001) Summary page 2.
- K012458: Model 6492 Unipolar Temporary Atrial Pacing Lead, Medtronic Vascular (2001) Summary page 2.
- K012459: Model 6494 Unipolar Temporary Myocardial Pacing Wire, Medtronic Vascular (2001) Summary page 2.
- K012460: Model 6495 Bipolar Temporary Myocardial Pacing Lead, Medtronic Vascular (2001) Summary page 2.
- K012452: Model 6500 Unipolar Temorary Myocardial Pacing Lead, Medtronic Vascular (2001) Summary page 2.

## Most influential descendants
- K171253: Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead (2017), 2 descendants of its own
- K190716: Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead (2019), 1 descendant of its own
- K242705: Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) (2025), 0 descendants of its own

## Indications for use
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only. The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only. The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only. The Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only. The Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K140972
Methodology: https://510kreport.com/methodology