510(k) · Cleared
ClearedK-Defib/Pace Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Katecho, Inc. · DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Cleared on May 14, 1992 after a 191-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 8 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- May 14, 1992
- Review
- 191 days
- Class
- Class II
- Product code
- DRO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- This deviceK914955 K-Defib/Pace ElectrodeKatecho, Inc. · 1992
- Descendant · cites it directly · 6 of its ownK971149 SVL-9130 Defibrillation ElectrodeSurvivalink Corp. · 1997 · Recalled
- Descendant · 2 generations on · 4 of its ownK082090 9131 Defibrillation ElectrodesCardiac Science Corporation · 2008
- Descendant · 3 generations on · 1 of its ownK122758 Powerheart G5 AedCardiac Science Corporation · 2014
- Descendant · 4 generations on · 0 of its ownK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
- Descendant · 3 generations on · 0 of its ownK142803 Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · Recalled (Class I)
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K142803 Skintact, various other tradenames3 generations on · 2014
Most influential descendants
Showing 5 of 7 · See all- K971149SVL-9130 Defibrillation ElectrodeSurvivalink Corp. · 1997 · cites it directly6descendants
- K0820909131 Defibrillation ElectrodesCardiac Science Corporation · 2008 · 2 generations on4descendants
- K122758Powerheart G5 AedCardiac Science Corporation · 2014 · 3 generations on1descendant
- K143714Powerheart G5 AEDCardiac Science Corporation · 2015 · 4 generations on0descendants
- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914955 | K-Defib/Pace Electrode | Katecho, Inc. | 1992 | — |
| +1 | K971149 | SVL-9130 Defibrillation Electrode | Survivalink Corp. | 1997 | 1 |
| +2 | K082090 | 9131 Defibrillation Electrodes | Cardiac Science Corporation | 2008 | — |
| +3 | K122758 | Powerheart G5 Aed | Cardiac Science Corporation | 2014 | — |
| +4 | K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015 | — |
| +3 | K142803 | Skintact, various other tradenames | Leonhard Lang GmbH | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 1 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K971149 | SVL-9130 Defibrillation Electrode | 1997 | 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.
- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K971149 (Survivalink Corp., 1997) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DRO devicesDRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRO
FDA has decided no DRO device since 2007.
Median 510(k) review, days · DRO
Too few DRO 510(k)s in any year since 2007 to give a median.
Recalls per year · DRO
12in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DRO
2in 2025
MAUDE reports naming product code DRO, 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 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 4 (4) | 2 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 49 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 64 |
| 2019 | 0 | — | 0 | 93 |
| 2020 | 0 | — | 12 | 19 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K914955 · printed Nov 5, 2026
Cite this page
510(k) Report. “K914955: K-Defib/Pace Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K914955
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026