510(k) · Cleared
ClearedSkintact Multifunction Electrodes, Model DF 21
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 7, 2004 as substantially equivalent to K955628 (Heartstream, Inc., 1996) after a 57-day review. Its family tree reaches back 1 generation to 1996. 2 of the 6 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Sep 7, 2004
- Review
- 57 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955628 (1996). 4 later devices descend from it, 1 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
- This deviceK041883 Skintact Multifunction Electrodes, Model DF 21Leonhard Lang GmbH · 2004
- Descendant · cites it directly · 3 of its ownK072233 Skintact Multifunctional Electrodes with DH02 Gel with Different…Leonhard Lang GmbH · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK142803 Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK103186 Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011
- Descendant · 2 generations on · 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 4 of 4 · See all- K072233Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible…Leonhard Lang GmbH · 2007 · cites it directly3descendants
- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · 2 generations on0descendants
- K103186Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011 · 2 generations on0descendants
- K081371Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955628 | Fore Runner External Defibrillator/Defibrillator Pads | Heartstream, Inc. | 1996 | — |
| 0 (this device) | 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 |
| +2 | K142803 | Skintact, various other tradenames | Leonhard Lang GmbH | 2014 | Class I |
| +2 | K103186 | Skintact Radiotransparent Multifunction Electrodes | Leonhard Lang GmbH | 2011 | — |
| +2 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K955628 | Fore Runner External Defibrillator/Defibrillator PadsSummary page 1…nt to the Philips HeartStart Defibrillation Pads (model DP2). Philips Medical Systems, formerly Heartstream, cleared the HeartStart Defibrillation Pads (model DP2) under K955628, a bundled submission including defibrillator and accessories. Device Description: Skintact ® Multifunction Electrodes are self-… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072233 | Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible… | 2007 | 3 |
Has anything in its family been recalled? (2 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.
- K081371Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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.
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?
The Skintact® Multifunction Electrodes 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/K041883 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041883: Skintact Multifunction Electrodes, Model DF 21.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041883
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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