510(k) · Cleared
ClearedOnestep Pediatric Mfe's
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, 2011 as substantially equivalent to K931787 (Zoll Medical Corp, 1993) and 1 other predicate after a 36-day review. Its family tree reaches back 3 generations to 2001. 1 of the 12 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- May 13, 2011
- Review
- 36 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003819 (2001). 4 ancestors in all, the oldest K931787 (1993). 7 later devices descend from it, 1 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001 · Recalled
- 2 generations backK022732 Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Recalled (Class I)
- 1 generation backK033474 Zoll Aed PlusZoll Medical Corp · 2004 · Recalled
- This deviceK110978 Onestep Pediatric Mfe'sZOLL Medical Corporation · 2011
- Descendant · cites it directly · 6 of its ownK120907 Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012
- Descendant · 2 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
- Descendant · 3 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014
- Descendant · 4 generations on · 1 of its ownK202375 ZOLL Propaq MZOLL Medical Corporation · 2021
- Descendant · 5 generations on · 0 of its ownK233354 WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes2 generations back · 2002
Most influential descendants
Showing 5 of 7 · See all- K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · cites it directly6descendants
- K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 2 generations on4descendants
- K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 3 generations on2descendants
- K202375ZOLL Propaq MZOLL Medical Corporation · 2021 · 4 generations on1descendant
- K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc. · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870A | Agilent Technologies, Inc. | 2001 | 4 |
| −2 | K022732 | Infant/Child Reduced Energy Electrodes | Medtronic Physio-Control Corp. | 2002 | Class I |
| −1 | K033474 | Zoll Aed Plus | Zoll Medical Corp | 2004 | 1 |
| 0 (this device) | K110978 | Onestep Pediatric Mfe's | ZOLL Medical Corporation | 2011 | — |
| +1 | K120907 | Zoll R Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | — |
| +2 | K133269 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2014 | — |
| +3 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | — |
| +4 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | — |
| +5 | K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 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.
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.
- 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K060559 | FDA’s K060559 is Zoll R Series Defibrillator Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K931787 | Zoll PD 5300Summary page 1…ed on 510O(k), K06559. Inaddition, the OneStep Pediatric Electrode is substantially equivalent to the originally cleared ZOLL pedi- padz solid gel identified on 510O(k), K931787 and pedi-padz 11cleared on K033474. The intent is to show that the OneStep Pediatric Electrodes will assist in providing therapy… | 1993 |
| * | K033474 | Zoll Aed PlusSummary page 1…the OneStep Pediatric Electrode is substantially equivalent to the originally cleared ZOLL pedi- padz solid gel identified on 510O(k), K931787 and pedi-padz 11cleared on K033474. The intent is to show that the OneStep Pediatric Electrodes will assist in providing therapy for defibrillation, cardioversion,… | 2004 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120907 | Zoll R Series | 2012 | 6 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K120907 (Zoll Medical Corporation, World Wide Headquarters, 2012) has gone furthest, with 6 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. 2011, this device’s year, is highlighted.
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?
Intended Use:
Defibrillation
Cardioversion
Noninvasive Pacing
ECG Monitoring
For use with ZOLL Defibrillators:
ZOLL Defibrillators, such as;
R Series
M Series
E Series
By Trained Personnel only, Including:
Physicians
Nurses
Paramedics
Emergency Medical Technicians
Cardiovascular Laboratory Technicians
The OneStep Pediatric Electrodes are indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110978: Onestep Pediatric Mfe's.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110978
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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