510(k) Report

510(k) · Cleared

Cleared

Zoll Pad with CPR Aid

K011541510(k) TraditionalCleared Apr 11, 2002328-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

Zoll Medical Corp · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Apr 11, 2002 after a 328-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided
Apr 11, 2002
Review
328 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2011: 3 descendants cleared2006: 1 descendant cleared2012: 5 descendants cleared2008: 2 descendants cleared2010: 2 descendants cleared2014: 5 descendants cleared2015: 2 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK011541 Zoll Pad with CPR AidZoll Medical Corp · 2002
  2. Descendant · cites it directly · 23 of its ownK041892 Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005
  3. Descendant · 2 generations on · 21 of its ownK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled
  4. Descendant · 3 generations on · 11 of its ownK100654 Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010
  5. Descendant · 3 generations on · 9 of its ownK110742 Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · Recalled
  6. Descendant · 4 generations on · 9 of its ownK102468 Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 22010: 22011: 32012: 52014: 52015: 22018: 12021: 12024: 1
2005high 5 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 24 · See all
  • K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005 · cites it directly23descendants
  • K060559Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · 2 generations on21descendants
  • K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010 · 3 generations on11descendants
  • K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 2011 · 3 generations on9descendants
  • K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011541Zoll Pad with CPR AidZoll Medical Corp2002—
+1K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation2005—
+2K060559Zoll R Series DefibrillatorZOLL Medical Corporation20061
+3K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters2010—
+3K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation20111
+4K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200820
201020
201130
201250
201450
201520
201810
202110
202410
FIG. 1 — Lineage of K011541, 2002–2024Source: 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
Get a 510(k) Report

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? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation200523

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, K041892 (ZOLL Medical Corporation, 2005) has gone furthest, with 23 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 Zoll Medical Corp

33 FDA decisions under this applicant name. See the company

  • K133484Zoll X SeriesZoll Medical Corp · 2014
  • K112660PocketcprZoll Medical Corp · 2012
  • K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009
  • K042007Zoll E Series DefibrillatorZoll Medical Corp · 20053 recalls
  • K042302Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes, Zoll…Zoll Medical Corp · 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/K011541 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011541: Zoll Pad with CPR Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011541

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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