510(k) · Cleared
Recalled · 2008Zoll Stat*Padz MWP Multi-Function Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZOLL Medical Corporation · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on May 13, 2005 as substantially equivalent to K981802 (Bio-Detek, Inc., 1998) and 2 other predicates after a 16-day review. Its family tree reaches back 1 generation to 1988. 10 later devices descend from it. It has been recalled once.
- Decided
- May 13, 2005
- Review
- 16 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K883375 (1988). 3 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK883375 Model #918 Multi-PadsCardiotronics, Inc. · 1988
- This deviceK051076 Zoll Stat*Padz MWP Multi-Function ElectrodesZOLL Medical Corporation · 2005
- Descendant · cites it directly · 9 of its ownK110742 Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK120907 Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012
- Descendant · 3 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
- Descendant · 4 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014
- Descendant · 5 generations on · 1 of its ownK202375 ZOLL Propaq MZOLL Medical Corporation · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · cites it directly9descendants
- K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 2 generations on6descendants
- K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 3 generations on4descendants
- K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 4 generations on2descendants
- K202375ZOLL Propaq MZOLL Medical Corporation · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883375 | Model #918 Multi-Pads | Cardiotronics, Inc. | 1988 | — |
| 0 (this device) | K051076 | Zoll Stat*Padz MWP Multi-Function Electrodes | ZOLL Medical Corporation | 2005 | — |
| +1 | K110742 | Onestep Adult Multi-Function Electrode | ZOLL Medical Corporation | 2011 | 1 |
| +2 | K120907 | Zoll R Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | — |
| +3 | K133269 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2014 | — |
| +4 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | — |
| +5 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 MKJ? 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? (3)
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 |
|---|---|---|---|
| * | K981802 | Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003Summary page 1…TM are substantially equivalent to those of the ZOLL stat.padz Adult Multi-function Electrodes K981802, cleared 11/25/1998, the Bio-Detek Tracerite ME40 SG ECG electrodes K964213, cleared 10/22/1996 and the Cardiotronics System… | 1998 |
| * | K964213 | Trace Rite Solid Gel Ecg ElectrodesSummary page 1…ntially equivalent to those of the ZOLL stat.padz Adult Multi-function Electrodes K981802, cleared 11/25/1998, the Bio-Detek Tracerite ME40 SG ECG electrodes K964213, cleared 10/22/1996 and the Cardiotronics Systems, Inc. MODEL #918 Multi-Pads K883375, cleared 08/30/1988. Description:… | 1996 |
| * | K883375 | Model #918 Multi-PadsSummary page 1…81802, cleared 11/25/1998, the Bio-Detek Tracerite ME40 SG ECG electrodes K964213, cleared 10/22/1996 and the Cardiotronics Systems, Inc. MODEL #918 Multi-Pads K883375, cleared 08/30/1988. Description: The disposable ZOLL statlpadzT M MwP Multi-function Electrodes are designed to provi… | 1988 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110742 | Onestep Adult Multi-Function Electrode | 2011 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 16, 2008 | Not classified | Z-2334-2008 | Process control | Multi-function electrode programmed as a Pediatric instead of Adult |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K110742 (ZOLL Medical Corporation, 2011) has gone furthest, with 9 descendants of its own.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, 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 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
ZOLL StatpadzTM MwP Multi-function Electrodes are indicated for the following clinical applications:
* Defibrillation
* Cardioversion
* Noninvasive Pacing
* Electrocardiograph Monitoring
These disposable electrodes will be used with the following devices:
* ZOLL PDTM 1200 Pacemaker/Defibrillator
* ZOLL PDTM 1400 Pacemaker/Defibrillator
* ZOLL PDTM 2000 Pacemaker/Defibrillator
* ZOLL D 900 Defibrillator
* ZOLL PD 1400 Defibrillator
* ZOLL D 2000 Defibrillator
* ZOLL 1600 Pacemaker/Defibrillator
* ZOLL 1700 Pacemaker/Defibrillator
* ZOLL M Series Equipment
* Future ZOLL Devices, as defined by ZOLL Operators Manuals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051076: Zoll Stat*Padz MWP Multi-Function Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051076
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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