510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Disposable Hydrogel Defibrillation Electrode/Pad

K960329510(k) TraditionalCleared Jul 2, 1996160-day reviewClass III21 CFR 870.5310Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Contour Medical Technology, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Jul 2, 1996 after a 160-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Jul 2, 1996
Review
160 days
Class
Class III
Product code
MKJ
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960329 Disposable Hydrogel Defibrillation Electrode/PadContour Medical Technology, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK022210 Multifunctional Electrode Models 9640, 9650Cardiac Science, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K022210Multifunctional Electrode Models 9640, 9650Cardiac Science, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960329Disposable Hydrogel Defibrillation Electrode/PadContour Medical Technology, Inc.1996—
+1K022210Multifunctional Electrode Models 9640, 9650Cardiac Science, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K960329, 1996–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in MKJ? 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
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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022210Multifunctional Electrode Models 9640, 9650Cardiac Science, Inc.20020

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 19, 2015Class IIZ-2547-2015Process controlMulti-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K022210 (Cardiac Science, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MKJ

48in 2025

2007: 72008: 132009: 82010: 42011: 112012: 102013: 72014: 112015: 62017: 42018: 202019: 252020: 522021: 412022: 192023: 242024: 272025: 482026 (partial year): 31
2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007: 69 days median2008: 141 days median2009: 165 days median2010: 250 days median2011: 36 days median2012: 197 days median2013: 191 days median2014: 196 days median2015: 156 days median
2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007: 122008: 242009: 372010: 352011: 72012: 5, 1 Class I2013: 42014: 24, 15 Class I2015: 12016: 2, 1 Class I2017: 6, 4 Class I2018: 32019: 6, 2 Class I2020: 22021: 42022: 32023: 112024: 52025: 12026 (partial year): 3
2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007: 3,9582008: 4,7522009: 6,7822010: 7,3992011: 8,1702012: 9,7322013: 14,9552014: 15,3992015: 16,1292016: 17,0622017: 16,6842018: 16,5912019: 16,8612020: 16,1972021: 16,3002022: 14,8672023: 13,7662024: 15,1092025: 13,315
2007high 17,062 (2016) · low 3,958 (2007)2025

MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007769123,958
200813141244,752
20098165376,782
20104250357,399
2011113678,170
2012101975 (1)9,732
20137191414,955
20141119624 (15)15,399
20156156116,129
20160—2 (1)17,062
20174—6 (4)16,684
201820—316,591
201925—6 (2)16,861
202052—216,197
202141—416,300
202219—314,867
202324—1113,766
202427—515,109
202548—113,315
202631—3—

More from Contour Medical Technology, Inc.

9 FDA decisions under this applicant name. See the company

  • K970391Quantum Edge Pediatric Defirbrillation ElectrodesContour Medical Technology, Inc. · 1997
  • K970125Noah Monitoring Electrode SystemContour Medical Technology, Inc. · 1997
  • K952807Temperature Probe-TP650Contour Medical Technology, Inc. · 1996
  • K952801Temperature Probe-TP250Contour Medical Technology, Inc. · 1996
  • K952804Temperature Probe-TP450Contour Medical Technology, Inc. · 1996

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The MKJ category page

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https://510kreport.com/device/K960329 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960329: Disposable Hydrogel Defibrillation Electrode/Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960329

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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