# K182839: Lifetech Cardio Model 8301 Temporary Pacemaker

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
- Decided: Feb 28, 2019 after 142 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: 2 generations back to K884331 (1989). 3 ancestors in all.
1 later device descends 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)
- K971474: Medtronic Model 5318 Temporary Pacemaker/Implant Tool, Medtronic Vascular (1997) Summary page 4.

## Most influential descendants
- K232721: Lifetech Cardio Temporary Pacemaker (2024), 0 descendants of its own

## Indications for use
The intended uses of Lifetech Cardio Model 8301 Temporary Pacemaker are 1. to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and 2. to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance. Lifetech Cardio Model 8301 Temporary Pacemaker is only intended to be operated 1. in a clinical setting, and 2. by trained professionals. Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that: 1. results from an acute and reversible cause and will likely not require permanent pacing, and 2. causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available. Examples of specific indications for temporary pacing may include: a) Sick sinus syndrome b) Sinus bradycardia c) Atrial and/or ventricular arrhythmias d) Complete atrioventricular block e) Asystole f) Bradycardia accompanied by congestive heart failure g) Patient support, management and evaluation before the implantation of implantable pacemaker h) Support during the replacement of implantable pacemaker i) Cardiac complications occurring during intervention or surgery j) Support after the cardiac surgery k) Acute myocardial infarction complicated with cardiac conduction block

Source page: https://510kreport.com/device/K182839
Methodology: https://510kreport.com/methodology