# K971474: Medtronic Model 5318 Temporary Pacemaker/Implant Tool

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jul 14, 1997 after 82 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- 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 K884331 (1989). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884331: Medtronic Model 5311B a-V Pacing System Analyzer, Medtronic Vascular (1989) Summary page 1.
- K910595: Model 5311B a-V Pacing System Analyzer, Medtronic Vascular (1991) Summary page 1.

## Most influential descendants
- K182839: Lifetech Cardio Model 8301 Temporary Pacemaker (2019), 1 descendant of its own
- K232721: Lifetech Cardio Temporary Pacemaker (2024), 0 descendants of its own

## Indications for use
The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is intended to be used in conjunction with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment. The Model 5318 can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. Specific indications for temporary cardiac pacing include, but are not limited to, the following: Sick sinus syndrome Sinus bradycardia Atrial and/or ventricular arrhythmias Complete heart block Cardiac arrest Bradycardia with congestive heart failure Support, management, and evaluation of a patient before implantable pacemaker implantation Support during implantable pacemaker replacement Cardiac complications during invasive or surgical procedures Support following cardiac surgery Acute myocardial infarction complicated by heart block The Model 5318 is also intended to be used by or on the order of a physician to determine sensing and stimulation thresholds and measure lead impedance of implantable lead systems during implantable pacemaker implantation.

Source page: https://510kreport.com/device/K971474
Methodology: https://510kreport.com/methodology