510(k) · Cleared
ClearedMedtronic Model 5318 Temporary Pacemaker/Implant Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DTE Pulse-Generator, Pacemaker, External
Cleared on Jul 14, 1997 as substantially equivalent to K884331 (Medtronic Vascular, 1989) and 1 other predicate after an 82-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Jul 14, 1997
- Review
- 82 days
- Class
- Class II
- Product code
- DTE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K884331 (1989). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK884331 Medtronic Model 5311B a-V Pacing System AnalyzerMedtronic Vascular · 1989
- This deviceK971474 Medtronic Model 5318 Temporary Pacemaker/Implant ToolMedtronic Vascular · 1997
- Descendant · cites it directly · 1 of its ownK182839 Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK232721 Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884331 | Medtronic Model 5311B a-V Pacing System Analyzer | Medtronic Vascular | 1989 | — |
| 0 (this device) | K971474 | Medtronic Model 5318 Temporary Pacemaker/Implant Tool | Medtronic Vascular | 1997 | — |
| +1 | K182839 | Lifetech Cardio Model 8301 Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2019 | — |
| +2 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K884331 | Medtronic Model 5311B a-V Pacing System AnalyzerSummary page 1…aker Generator Function Analyzer 21 CFR 870.3630, Class III Product Code: DTC Model Number | ' Document Control Apfifoval Date : _ Number : 5311B Pacing System Analyzer K884331 January 10, 1989 K910595 May 7, 1991 D. Device Description The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is a han… | 1989 |
| * | K910595 | Model 5311B a-V Pacing System AnalyzerSummary page 1…nalyzer 21 CFR 870.3630, Class III Product Code: DTC Model Number | ' Document Control Apfifoval Date : _ Number : 5311B Pacing System Analyzer K884331 January 10, 1989 K910595 May 7, 1991 D. Device Description The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is a hand-held, temporary, batter… | 1991 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182839 | Lifetech Cardio Model 8301 Temporary Pacemaker | 2019 | 1 |
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?
How does its category compare?
All DTE devicesDTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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…
Read the full statement (154 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971474 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971474: Medtronic Model 5318 Temporary Pacemaker/Implant Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971474
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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