510(k) · Cleared
ClearedMPC (Model 7000) External Temporary Pacemaker System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paladin Medical, Inc. · DTE Pulse-Generator, Pacemaker, External
Cleared on Aug 29, 1997 as substantially equivalent to K821791 (American Pacemaker Corp., 1982) after a 214-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Aug 29, 1997
- Review
- 214 days
- Class
- Class II
- Product code
- DTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K821791 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK821791 External Pulse Generator - EV4542American Pacemaker Corp. · 1982
- This deviceK970347 MPC (Model 7000) External Temporary Pacemaker SystemPaladin Medical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821791 | External Pulse Generator - EV4542 | American Pacemaker Corp. | 1982 | — |
| 0 (this device) | K970347 | MPC (Model 7000) External Temporary Pacemaker System | Paladin Medical, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K821791 | External Pulse Generator - EV4542Summary page 1…C 7000 External Temporary Pacemaker System COMMON NAME. External Temporary Pacemaker SUBSTANTIALLY EQUIVALENT TO: Pace Medical, Inc. Model 4542 Extemal Pulse Generator (K821791) /1(@/ 24 DESCRIPTION OF THE DEVICE: The MPC Model 7000 External Temporary Pacemaker System is a battery powere… | 1982 |
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?
- Its one ancestor has no recall.
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 MPC Model 7000 External Temporary Pacemaker System is indicated for temporary (1-10 days typical) ventricular cardiac pacing in a controlled clinical environment.
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/K970347 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970347: MPC (Model 7000) External Temporary Pacemaker System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970347
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