510(k) · Cleared
Recalled · Class II · 2019Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Medical Corp · DTE Pulse-Generator, Pacemaker, External
Cleared on Jun 5, 1996 after a 106-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 5, 1996
- Review
- 106 days
- Class
- Class II
- Product code
- DTE
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK960676 Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model…Zoll Medical Corp · 1996
- Descendant · cites it directly · 0 of its ownK040256 Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model…Bio-Detek, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040256Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005Bio-Detek, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960676 | Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004 | Zoll Medical Corp | 1996 | — |
| +1 | K040256 | Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005 | Bio-Detek, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K040256 | Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005 | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2019 | Class II | Z-1945-2019 | Process control | Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040256 (Bio-Detek, Inc., 2004) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K960676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960676: Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960676
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026