510(k) Report

510(k) · Cleared

Cleared

Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003

K981802510(k) TraditionalCleared Nov 25, 1998188-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 25, 1998 after a 188-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.

Decided
Nov 25, 1998
Review
188 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2011: 1 descendant cleared2014: 4 descendants cleared2012: 1 descendant cleared2015: 2 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK981802 Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003Bio-Detek, Inc. · 1998
  2. Descendant · cites it directly · 10 of its ownK051076 Zoll Stat*Padz MWP Multi-Function ElectrodesZOLL Medical Corporation · 2005 · Recalled
  3. Descendant · 2 generations on · 9 of its ownK110742 Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · Recalled
  4. Descendant · 3 generations on · 6 of its ownK120907 Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012
  5. Descendant · 4 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
  6. Descendant · 5 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005: 12011: 12012: 12014: 42015: 22021: 12024: 1
2005high 4 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 11 · See all
  • K051076Zoll Stat*Padz MWP Multi-Function ElectrodesZOLL Medical Corporation · 2005 · cites it directly10descendants
  • K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · 2 generations on9descendants
  • K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 3 generations on6descendants
  • K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 4 generations on4descendants
  • K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981802Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003Bio-Detek, Inc.1998—
+1K051076Zoll Stat*Padz MWP Multi-Function ElectrodesZOLL Medical Corporation20051
+2K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation20111
+3K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters2012—
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters2014—
+5K141774Zoll X SeriesZOLL Medical Corporation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201110
201210
201440
201520
202110
202410
FIG. 1 — Lineage of K981802, 1998–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K051076Zoll Stat*Padz MWP Multi-Function ElectrodesZOLL Medical Corporation200510

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, K051076 (ZOLL Medical Corporation, 2005) has gone furthest, with 10 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—

What is it indicated for?

Modified stat-padz Adult Multi-Function Electrodes will be used for the following clinical applications: Defibritiation Cardioversion Noninvasive Pacing Electrocardiograph Monitoring In conjuction with these devices: ZOLL PD™ 1200 Pacemaker/Defibrillator ZOLL PD™ 1400 Pacemaker/Defibrillator ZOLL PD™ 2000 Pacemaker/Defibrillator ZOLL D 900 Defibrillator ZOLL D 1400 Defibrillator ZOLL D 2000 Defibrillator ZOLL 1600 Pacemaker/Defibrillator ZOLL 1700…

Read the full statement (81 words)

Modified stat-padz Adult Multi-Function Electrodes will be used for the following clinical applications:

Defibritiation

Cardioversion

Noninvasive Pacing

Electrocardiograph Monitoring

In conjuction with these devices:

ZOLL PD™ 1200 Pacemaker/Defibrillator

ZOLL PD™ 1400 Pacemaker/Defibrillator

ZOLL PD™ 2000 Pacemaker/Defibrillator

ZOLL D 900 Defibrillator

ZOLL D 1400 Defibrillator

ZOLL D 2000 Defibrillator

ZOLL 1600 Pacemaker/Defibrillator

ZOLL 1700 Pacemsker/Defibrillator

ZOLL NTP 1000 Noninvasive Temporary Pacemaker

ZOLL M Series

By trained medical personnel, including:

Physicians

Nurses

Paramedics

Emergency Medical Technicians (EMT)

Cardiovascular Laboratory Technicians

In typical settings.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

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/K981802 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981802: Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981802

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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