510(k) · Cleared
ClearedCPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Detek, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on May 2, 2015 as substantially equivalent to K100565 (Bio-Detek, Inc., 2010) and 1 other predicate after a 93-day review. Its family tree reaches back 9 generations to 1997. 1 of the 29 devices in its family, counting itself, has a Class I recall.
- Decided
- May 2, 2015
- Review
- 93 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K962603 (1997). 28 ancestors in all, the oldest K883375 (1988). No later device cites it as a predicate yet. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
- 2 generations backK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled
- 1 generation backK110742 Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · Recalled
- This deviceK150198 CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 3 generations backK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
- 2 generations backK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled
- 1 generation backK110742 Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · Recalled
- This deviceK150198 CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc. · 2015
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes5 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −3 | K042007 | Zoll E Series Defibrillator | Zoll Medical Corp | 2005 | 3 |
| −2 | K060559 | Zoll R Series Defibrillator | ZOLL Medical Corporation | 2006 | 1 |
| −1 | K110742 | Onestep Adult Multi-Function Electrode | ZOLL Medical Corporation | 2011 | 1 |
| 0 (this device) | K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | Bio-Detek, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 1 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K100565 | Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300…Summary page 4…Cardiopulmonary Resuscitation Aid (LIX; 21 CFR 870.5200) Predicate Devices K100565 - Dura-padz Reusable Defibrillation Electrode used in… | 2010 |
| * | K110742 | Onestep Adult Multi-Function ElectrodeSummary page 4…Defibrillation Electrode used in conjunction with Dura-padz Gel K110742 - ZOLL OneStep Adult Multi- Function Electrode Substantial Equivalence – Non-Clini… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 28 ancestors have a recall of any class; 1 has a Class I recall.
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. 2015, 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?
Defibrillation ECG Monitoring Cardioversion CPR Feedback The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules: AED Pro M Series E Series R Series The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including: Physicians Nurses Paramedics Emergency Medical…
Read the full statement (117 words)
Defibrillation
ECG Monitoring
Cardioversion
CPR Feedback
The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:
AED Pro
M Series
E Series
R Series
The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:
Physicians
Nurses
Paramedics
Emergency Medical Technicians
Cardiovascular Laboratory Technicians
First Responders
The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators.
The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150198 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150198: CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150198
Report an extraction error
Are you the manufacturer?
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