510(k) · Cleared
Recalled · Class I · 2014Skintact Pediatric Multifunction Electrodes with DH03 Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leonhard Lang GmbH · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Sep 24, 2008 as substantially equivalent to K992977 (Hewlett-Packard Co., 1999) and 1 other predicate after a 132-day review. Its family tree reaches back 3 generations to 1996. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Sep 24, 2008
- Review
- 132 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955628 (1996). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
- 2 generations backK041883 Skintact Multifunction Electrodes, Model DF 21Leonhard Lang GmbH · 2004
- 1 generation backK072233 Skintact Multifunctional Electrodes with DH02 Gel with Different…Leonhard Lang GmbH · 2007 · Recalled
- This deviceK081371 Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955628 | Fore Runner External Defibrillator/Defibrillator Pads | Heartstream, Inc. | 1996 | — |
| −2 | K041883 | Skintact Multifunction Electrodes, Model DF 21 | Leonhard Lang GmbH | 2004 | — |
| −1 | K072233 | Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors… | Leonhard Lang GmbH | 2007 | 2 |
| 0 (this device) | K081371 | Skintact Pediatric Multifunction Electrodes with DH03 Gel | Leonhard Lang GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K992977 | Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504ASummary page 1…ubmission: new device Substantial Equivalence: Skintact® Pediatric Multifunction Electrodes with DHO3 Gel are substantially equivalent to the stated predicate devices: K992977 Hewlett Packard Multifunction Pediatric Defibrillation Electrodes K072233 Leonhard Lang Skintact® Multifunction Electrodes with D… | 1999 |
| * | K072233 | Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible…Summary page 1…function Electrodes with DHO3 Gel are substantially equivalent to the stated predicate devices: K992977 Hewlett Packard Multifunction Pediatric Defibrillation Electrodes K072233 Leonhard Lang Skintact® Multifunction Electrodes with DHO2 Gel available with different connectors compatible with d… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2014 | Class I | Z-0802-2015 | Component design/selection | The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2008, 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?
Skintact® Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators; Medtronic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081371: Skintact Pediatric Multifunction Electrodes with DH03 Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081371
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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