510(k) Report

510(k) · Cleared

Cleared

Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005

K040256510(k) TraditionalCleared Apr 9, 200465-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 Apr 9, 2004 as substantially equivalent to K915159 (Zmi Corp., 1992) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 1992.

Decided
Apr 9, 2004
Review
65 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K915159 (1992). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK915159 · Pediatric Multi-Function Electrodes · Zmi Corp. · 1992 · recalled1990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K915159 · Pediatric Multi-Function Electrodes · Zmi Corp. · 1992 · recalled0
  1. Root · 1 generation backK915159 Pediatric Multi-Function ElectrodesZmi Corp. · 1992 · Recalled
  2. This deviceK040256 Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model…Bio-Detek, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K915159Pediatric Multi-Function ElectrodesZmi Corp.19921
0 (this device)K040256Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005Bio-Detek, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K040256, 1992–2004Source: 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), 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.

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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K915159Pediatric Multi-Function Electrodes
Summary page 1
…Function Electrode Predicate Device: ZOLL Pediatric Multi-Function Electrode K915159A & ZOLL stat-padz TM Radiolucent Adult Multi-Function Electrode K960676 Device…
Zmi Corp.19921
*K960676Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004
Summary page 1
…ode K915159A & ZOLL stat-padz TM Radiolucent Adult Multi-Function Electrode K960676 Device Description and Intended Use: The pedi-padzTM Radiolucent Pediatric Multi-Function Electrodes will connect t…
Zoll Medical Corp19961

Also cleared against K915159: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 2 of the 2 ancestors have a recall of any class.
  • 1 other device also cites its predicate K915159.

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—

What is it indicated for?

The pediopadzTM Radiolucent MiFE's are intended to be used on pediatric patients, 0-8 years of age at <55 lbs/25kg weight, for defibrillation, non-invasive pacing, cardioversion, and ecg monitoring in conjunction with ZOLL Pacemaker/Defibrillator equipment.

Indications for use as stated in the FDA summary.

Also cleared against K915159

1 other device cites the same predicate.

  • K072430Zoll Pedipadz Reduced Energy ElectrodeZOLL Medical Corporation · 20071 recall

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
  • K100565Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325Bio-Detek, Inc. · 2010
  • K071321PocketcprBio-Detek, Inc. · 2007

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/K040256 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040256: Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040256

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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