510(k) · Cleared
ClearedCareLink SmartSync Device Manager - Pacing System Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTA Tester, Pacemaker Electrode Function
Cleared on Feb 28, 2017 as substantially equivalent to P890003 (Medtronic, Inc., 1989) and 1 other predicate after a 123-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Feb 28, 2017
- Review
- 123 days
- Class
- Class II
- Product code
- DTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P890003 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backP890003 Synergyst II Pulse Generator Models 7070 & 7071Medtronic, Inc. · 1989 · Recalled
- This deviceK163008 CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P890003 | Synergyst II Pulse Generator Models 7070 & 7071 | Medtronic, Inc. | 1989 | 13 |
| 0 (this device) | K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | Medtronic, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 DTA? 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? (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 |
|---|---|---|---|
| * | P890003 | Synergyst II Pulse Generator Models 7070 & 7071Summary page 4…cables (previously approved) and accessories are substantially equivalent to the following predicate device: • Medtronic Model 2290 Lead Analyzer approved on 13MAR2002 P890003/S065. • Medtronic Model 5311B A-V Pacing System Analyzer cleared on 07MAY1991 K910595. Device Description Device Identificatio… | 1989 |
| * | K910595 | Model 5311B a-V Pacing System AnalyzerSummary page 4…ng predicate device: • Medtronic Model 2290 Lead Analyzer approved on 13MAR2002 P890003/S065. • Medtronic Model 5311B A-V Pacing System Analyzer cleared on 07MAY1991 K910595. Device Description Device Identification: The following is a list all key device components included in the submission: •… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All DTA devicesDTA Tester, Pacemaker Electrode Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DTA
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DTA
Too few DTA 510(k)s in any year since 2007 to give a median.
Recalls per year · DTA
No recall names DTA since 2007.
Adverse event reports per year · DTA
1in 2023
MAUDE reports naming product code DTA, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base’s ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163008: CareLink SmartSync Device Manager - Pacing System Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163008
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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