510(k) Report

510(k) · Cleared

Cleared

Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325

K100565510(k) TraditionalCleared Nov 16, 2010260-day reviewClass III21 CFR 870.5310

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

Bio-Detek, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Nov 16, 2010 after a 260-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Nov 16, 2010
Review
260 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2015: 1 descendant cleared2010201520202025
  1. This deviceK100565 Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel)…Bio-Detek, Inc. · 2010
  2. Descendant · cites it directly · 0 of its ownK150198 CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K100565Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model…Bio-Detek, Inc.2010—
+1K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K100565, 2010–2015Source: 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 has not posted a summary or statement for it, 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
K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K150198 (Bio-Detek, Inc., 2015) 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. 2010, this device’s year, is highlighted.

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 Bio-Detek, Inc.

17 FDA decisions under this applicant name. See the company

  • K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc. · 2015
  • K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc. · 2015
  • K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc. · 2014
  • K071321PocketcprBio-Detek, Inc. · 2007
  • K040056Bio-Detek Electrode Adapter, Model R2001-90Bio-Detek, Inc. · 2004

Recent decisions in MKJ

The MKJ category page

  • P160015/S029AED 3 Defibrillator with Uni-PadzZOLL Medical Corporation · 2026
  • P160022/S056ZOLL R Series Monitor/DefibrillatorZOLL Medical Corporation · 2026
  • P160022/S054X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode…ZOLL Medical Corporation · 2026
  • P160026/S074Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak…Physio-Control, Inc. · 2026
  • P160026/S073LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc. · 2026

https://510kreport.com/device/K100565 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100565: Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100565

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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