510(k) · Cleared
Recalled · 2009Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible with Different Defibrillators
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 Oct 5, 2007 as substantially equivalent to K041883 (Leonhard Lang GmbH, 2004) after a 56-day review. Its family tree reaches back 2 generations to 1996. 2 of the 6 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 5, 2007
- Review
- 56 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955628 (1996). 3 later devices descend from it, 3 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
- 1 generation backK041883 Skintact Multifunction Electrodes, Model DF 21Leonhard Lang GmbH · 2004
- This deviceK072233 Skintact Multifunctional Electrodes with DH02 Gel with Different…Leonhard Lang GmbH · 2007
- Descendant · cites it directly · 0 of its ownK142803 Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK103186 Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011
- Descendant · cites it directly · 0 of its ownK081371 Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · cites it directly0descendants
- K103186Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011 · cites it directly0descendants
- K081371Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955628 | Fore Runner External Defibrillator/Defibrillator Pads | Heartstream, Inc. | 1996 | — |
| −1 | K041883 | Skintact Multifunction Electrodes, Model DF 21 | Leonhard Lang GmbH | 2004 | — |
| 0 (this device) | K072233 | Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors… | Leonhard Lang GmbH | 2007 | — |
| +1 | K142803 | Skintact, various other tradenames | Leonhard Lang GmbH | 2014 | Class I |
| +1 | K103186 | Skintact Radiotransparent Multifunction Electrodes | Leonhard Lang GmbH | 2011 | — |
| +1 | K081371 | Skintact Pediatric Multifunction Electrodes with DH03 Gel | Leonhard Lang GmbH | 2008 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2011 | 1 | 0 |
| 2014 | 1 | 1 |
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.
2 devices in this family have 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? (1)
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 |
|---|---|---|---|
| * | K041883 | Skintact Multifunction Electrodes, Model DF 21Summary page 1…able with different connectors compatible with different defibfrillators are equivalent to Skintact" Multifunction electrodes with DHO02 Gel (cleared in existing 5 10(k) K041883) There are no changes to the materials used in the construction. Test results are prov'ided which show that this change does not… | 2004 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2009 | Not classified | Z-2233-2009 | Nonconforming Material/Component | A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the… |
| Jul 10, 2009 | Not classified | Z-2234-2009 | Nonconforming Material/Component | A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the… |
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.
- K081371Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142803 (Leonhard Lang GmbH, 2014) has gone furthest, with 0 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. 2007, 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® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators are for use on adults and children over eight years old for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072233: Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible with Different Defibrillators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072233
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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