510(k) · Cleared
ClearedLifetech Cardio Model 8301 Temporary Pacemaker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. · DTE Pulse-Generator, Pacemaker, External
Cleared on Feb 28, 2019 as substantially equivalent to K971474 (Medtronic Vascular, 1997) after a 142-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Feb 28, 2019
- Review
- 142 days
- Class
- Class II
- Product code
- DTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K884331 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK884331 Medtronic Model 5311B a-V Pacing System AnalyzerMedtronic Vascular · 1989
- 1 generation backK971474 Medtronic Model 5318 Temporary Pacemaker/Implant ToolMedtronic Vascular · 1997
- This deviceK182839 Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK232721 Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884331 | Medtronic Model 5311B a-V Pacing System Analyzer | Medtronic Vascular | 1989 | — |
| −1 | K971474 | Medtronic Model 5318 Temporary Pacemaker/Implant Tool | Medtronic Vascular | 1997 | — |
| 0 (this device) | K182839 | Lifetech Cardio Model 8301 Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2019 | — |
| +1 | K232721 | Lifetech Cardio Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DTE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTE device
- #1 K232721 Lifetech Cardio Temporary Pacemakerscore 7.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971474 | Medtronic Model 5318 Temporary Pacemaker/Implant ToolSummary page 4…evice Trade Name Medtronic Model 5318 Temporary Pacemaker / Implant Tool 510(k) Number K971474 Product Code DTE Manufacturer Medtronic, Inc. C. Device Description Lifetech Card… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232721 | Lifetech Cardio Temporary Pacemaker | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 21.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232721 (Shenzhen Lifetech Cardio Medical Electronics Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DTE devicesDTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DTE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTE
Too few DTE 510(k)s in any year since 2007 to give a median.
Recalls per year · DTE
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTE
636in 2025
MAUDE reports naming product code DTE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 17 |
| 2008 | 0 | — | 0 | 22 |
| 2009 | 0 | — | 0 | 39 |
| 2010 | 0 | — | 2 | 335 |
| 2011 | 0 | — | 0 | 1,865 |
| 2012 | 0 | — | 0 | 1,786 |
| 2013 | 2 | — | 0 | 98 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 1 | — | 0 | 342 |
| 2016 | 2 | — | 0 | 496 |
| 2017 | 0 | — | 0 | 654 |
| 2018 | 2 | — | 0 | 956 |
| 2019 | 2 | — | 0 | 1,001 |
| 2020 | 1 | — | 0 | 1,092 |
| 2021 | 0 | — | 0 | 899 |
| 2022 | 0 | — | 0 | 833 |
| 2023 | 0 | — | 0 | 650 |
| 2024 | 1 | — | 0 | 620 |
| 2025 | 1 | — | 0 | 636 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (187 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182839: Lifetech Cardio Model 8301 Temporary Pacemaker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182839
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026