510(k) · Cleared
ClearedPaceart Optima System Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · KRE Analyzer, Pacemaker Generator Function, Indirect
Cleared on Jun 8, 2011 as substantially equivalent to K024278 (Medtronic Vascular, 2003) after an 89-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 8, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- KRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952065 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK952065 Paceart CardiovoicePaceart, Inc. · 1996
- 1 generation backK024278 Paceart SystemMedtronic Vascular · 2003 · Recalled
- This deviceK110693 Paceart Optima System SoftwareMedtronic, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK142349 TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952065 | Paceart Cardiovoice | Paceart, Inc. | 1996 | — |
| −1 | K024278 | Paceart System | Medtronic Vascular | 2003 | 2 |
| 0 (this device) | K110693 | Paceart Optima System Software | Medtronic, Inc. | 2011 | — |
| +1 | K142349 | TM eCloud ECG Analysis System | Telemed Solutions, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 KRE? 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? (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 |
|---|---|---|---|
| * | K024278 | Paceart SystemSummary page 1…alent to the Paceart® System Software, which was cleared as padt of the following predicate device/system. *Medtronic Paceart System cleared via 5 10(k), K024278, on May 29, 2003 Device Description The Medtronic Paceart Optima System Software, Model POS 12D3, is intended for use… | 2003 |
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 |
|---|---|---|---|
| K142349 | TM eCloud ECG Analysis System | 2015 | 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 15 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K142349 (Telemed Solutions, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KRE devicesKRE Analyzer, Pacemaker Generator Function, Indirect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KRE
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KRE
Too few KRE 510(k)s in any year since 2007 to give a median.
Recalls per year · KRE
No recall names KRE since 2007.
Adverse event reports per year · KRE
2in 2023
MAUDE reports naming product code KRE, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or Implantable Cardioverter Defibrillators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110693: Paceart Optima System Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110693
Report an extraction error
Are you the manufacturer?
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