510(k) · Cleared
ClearedModel #918 Multi-Pads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiotronics, Inc. · DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Cleared on Aug 30, 1988 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 30, 1988
- Review
- 21 days
- Class
- Class II
- Product code
- DRO
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK883375 Model #918 Multi-PadsCardiotronics, Inc. · 1988
- Descendant · cites it directly · 10 of its ownK051076 Zoll Stat*Padz MWP Multi-Function ElectrodesZOLL Medical Corporation · 2005 · Recalled
- Descendant · 2 generations on · 9 of its ownK110742 Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · Recalled
- Descendant · 3 generations on · 6 of its ownK120907 Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012
- Descendant · 4 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
- Descendant · 5 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K051076Zoll Stat*Padz MWP Multi-Function ElectrodesZOLL Medical Corporation · 2005 · cites it directly10descendants
- K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · 2 generations on9descendants
- K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 3 generations on6descendants
- K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 4 generations on4descendants
- K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883375 | Model #918 Multi-Pads | Cardiotronics, Inc. | 1988 | — |
| +1 | K051076 | Zoll Stat*Padz MWP Multi-Function Electrodes | ZOLL Medical Corporation | 2005 | 1 |
| +2 | K110742 | Onestep Adult Multi-Function Electrode | ZOLL Medical Corporation | 2011 | 1 |
| +3 | K120907 | Zoll R Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | — |
| +4 | K133269 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2014 | — |
| +5 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRO? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051076 | Zoll Stat*Padz MWP Multi-Function Electrodes | 2005 | 10 |
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?
- Of its descendants, K051076 (ZOLL Medical Corporation, 2005) has gone furthest, with 10 descendants of its own.
How does its category compare?
All DRO devicesDRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRO
FDA has decided no DRO device since 2007.
Median 510(k) review, days · DRO
Too few DRO 510(k)s in any year since 2007 to give a median.
Recalls per year · DRO
12in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DRO
2in 2025
MAUDE reports naming product code DRO, 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 | 7 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 4 (4) | 2 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 49 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 64 |
| 2019 | 0 | — | 0 | 93 |
| 2020 | 0 | — | 12 | 19 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K883375 · printed Nov 5, 2026
Cite this page
510(k) Report. “K883375: Model #918 Multi-Pads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K883375
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026