510(k) · Cleared
ClearedModel 5311B a-V Pacing System Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DTC Analyzer, Pacemaker Generator Function
Cleared on May 7, 1991 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 7, 1991
- Review
- 84 days
- Class
- Class II
- Product code
- DTC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK910595 Model 5311B a-V Pacing System AnalyzerMedtronic Vascular · 1991
- Descendant · cites it directly · 2 of its ownK971474 Medtronic Model 5318 Temporary Pacemaker/Implant ToolMedtronic Vascular · 1997
- Descendant · 2 generations on · 1 of its ownK182839 Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK232721 Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK163008 CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K971474Medtronic Model 5318 Temporary Pacemaker/Implant ToolMedtronic Vascular · 1997 · cites it directly2descendants
- K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2019 · 2 generations on1descendant
- K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2024 · 3 generations on0descendants
- K163008CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910595 | Model 5311B a-V Pacing System Analyzer | Medtronic Vascular | 1991 | — |
| +1 | K971474 | Medtronic Model 5318 Temporary Pacemaker/Implant Tool | Medtronic Vascular | 1997 | — |
| +2 | K182839 | Lifetech Cardio Model 8301 Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2019 | — |
| +3 | K232721 | Lifetech Cardio Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2024 | — |
| +1 | K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | Medtronic, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DTC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K971474 (Medtronic Vascular, 1997) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DTC devicesDTC Analyzer, Pacemaker Generator Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTC
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DTC
Too few DTC 510(k)s in any year since 2007 to give a median.
Recalls per year · DTC
No recall names DTC since 2007.
Adverse event reports per year · DTC
1,159in 2025
MAUDE reports naming product code DTC, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 34 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 138 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 636 |
| 2022 | 0 | — | 0 | 218 |
| 2023 | 0 | — | 0 | 215 |
| 2024 | 0 | — | 0 | 1,076 |
| 2025 | 0 | — | 0 | 1,159 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910595 · printed Nov 3, 2026
Cite this page
510(k) Report. “K910595: Model 5311B a-V Pacing System Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K910595
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026