510(k) · Cleared
Recalled · Class I · 2014700-F Series Stimulation Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiotronics Systems, Inc. · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Dec 11, 1996 after a 34-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 4 times, including 2 Class I recalls.
- Decided
- Dec 11, 1996
- Review
- 34 days
- Class
- Class II
- Product code
- LDD
- Recalls
- 4 (2 Class I)
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK964469 700-F Series Stimulation ElectrodesCardiotronics Systems, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK150349 Rapid Hair Removal PadsFull Power Aed · 2015
Most influential descendants
Showing 1 of 1 · See all- K150349Rapid Hair Removal PadsFull Power Aed · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964469 | 700-F Series Stimulation Electrodes | Cardiotronics Systems, Inc. | 1996 | — |
| +1 | K150349 | Rapid Hair Removal Pads | Full Power Aed | 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 LDD device
- #1 K200849 Tempus LS - Manualscore 1.3 · 13 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 |
|---|---|---|---|
| * | — | R2 Medical Systems 600 Series electrode Named without a submission number |
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 |
|---|---|---|---|
| K150349 | Rapid Hair Removal Pads | 2015 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2014 | Class I | Z-0461-2015 | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient… |
| Nov 6, 2014 | Class I | Z-0462-2015 | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient… |
| Mar 31, 2011 | Not classified | Z-0856-2012 | Employee error | The specific lot was assembled without the rivet cover. |
| Mar 9, 2011 | Not classified | Z-0735-2012 | Packaging process control | The product lot was assembled with an R2 Connector, rather than a Zoll Connector. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K150349 (Full Power Aed, 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LDD devicesLDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LDD
124in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDD
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDD
74in 2025
MAUDE reports naming product code LDD, 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 | 550 |
| 2008 | 2 | — | 11 | 1,214 |
| 2009 | 0 | — | 1 | 1,057 |
| 2010 | 2 | — | 0 | 635 |
| 2011 | 4 | 124 | 1 | 386 |
| 2012 | 0 | — | 0 | 398 |
| 2013 | 0 | — | 0 | 602 |
| 2014 | 1 | — | 2 (2) | 481 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 0 | — | 0 | 58 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 0 | — | 0 | 28 |
| 2019 | 1 | — | 0 | 34 |
| 2020 | 1 | — | 1 | 19 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 264 |
| 2024 | 0 | — | 2 | 160 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 700-F series elecirodes are disposable electrodes for extemnal cardiac stimulation and monitoring. Electrodes of this design are suitable for extermal pacing, external defibrillation, synchronized cardloversion and ECG monitoring. The expected patient population for the use of these devices includes adults and children. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. The duration for use…
Read the full statement (139 words)
The 700-F series elecirodes are disposable electrodes for extemnal cardiac stimulation and monitoring. Electrodes of this design are suitable for extermal pacing, external defibrillation, synchronized cardloversion and ECG monitoring. The expected patient population for the use of these devices includes adults and children. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. The duration for use is intended to be less than 24 hours. Individual catalog numbers are labeled for more specific use based primarily on the Interface connector and cable system which defines the host external device, such as an external defibrillator.
The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labeled with one or more of the following intended uses:
External Defibrillation
External Pacing
ECG Monitoring
Synchonized Cardioversion
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964469: 700-F Series Stimulation Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964469
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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