510(k) Report

510(k) · Cleared

Cleared

Zoll E Series with 2010 Aha Guidlines Software Update

K110168510(k) SpecialCleared Feb 17, 201128-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 Corporation, World Wide Headquarters · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Feb 17, 2011 as substantially equivalent to K042007 (Zoll Medical Corp, 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 7 generations to 1997. 1 of the 35 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.

Decided
Feb 17, 2011
Review
28 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
2

Its longest line of descent runs back 7 generations to K962603 (1997). 19 ancestors in all, the oldest K945071 (1995). 15 later devices descend from it, 2 citing it directly. 1 of the 35 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2000: 1 other ancestor1999: 4 other ancestors2002: 1 other ancestor, 1 with a Class I recall12001: 1 other ancestor1996: 2 other ancestors1995: 1 other ancestor2012: 3 descendants cleared2011: 1 descendant cleared2014: 5 descendants cleared2015: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant clearedK962603 · Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables · Masimo Corp. · 1997K973887 · Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables · Masimo Corp. · 1998K982255 · Model 2000 Pulse Oximeter · Ivy Biomedical Systems, Inc. · 1998K991823 · N-395 Pulse Oximeter, Model N-395 · Nellcor Puritan Bennett, Inc. · 1999K012451 · Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 · Welch Allyn Protocol, Inc. · 2001K032363 · Zoll M Series Nibp Option · Zoll Medical Corp · 2003K042007 · Zoll E Series Defibrillator · Zoll Medical Corp · 2005 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 1 other ancestor, 1 with a Class I recall14 generations back: 4 other ancestors5 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K042007 · Zoll E Series Defibrillator · Zoll Medical Corp · 2005 · recalledK032363 · Zoll M Series Nibp Option · Zoll Medical Corp · 2003K012451 · Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 · Welch Allyn Protocol, Inc. · 2001K991823 · N-395 Pulse Oximeter, Model N-395 · Nellcor Puritan Bennett, Inc. · 1999K982255 · Model 2000 Pulse Oximeter · Ivy Biomedical Systems, Inc. · 1998K973887 · Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables · Masimo Corp. · 1998K962603 · Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables · Masimo Corp. · 1997−50+5
  1. Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
  2. 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
  3. 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
  4. 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
  5. 3 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
  6. 2 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
  7. 1 generation backK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
  8. This deviceK110168 Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011
  9. Descendant · cites it directly · 10 of its ownK111594 Zoll E SeriesZoll Medical Corporation, World Wide Headquarters · 2011
  10. Descendant · cites it directly · 8 of its ownK112432 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · Recalled
  11. Descendant · 2 generations on · 6 of its ownK120907 Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012
  12. Descendant · 2 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
  13. Descendant · 2 generations on · 3 of its ownK121367 Zoll Propaq XMZOLL Medical Corporation · 2012 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2011: 12012: 32014: 52015: 22018: 12020: 12021: 12024: 1
2011high 5 (2014) · low 0 (2013)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 15 · See all
  • K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters · 2011 · cites it directly10descendants
  • K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · cites it directly8descendants
  • K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 2 generations on6descendants
  • K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 2 generations on4descendants
  • K121367Zoll Propaq XMZOLL Medical Corporation · 2012 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K962603Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp.1997—
−6K973887Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and CablesMasimo Corp.1998—
−5K982255Model 2000 Pulse OximeterIvy Biomedical Systems, Inc.1998—
−4K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc.1999—
−3K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc.2001—
−2K032363Zoll M Series Nibp OptionZoll Medical Corp2003—
−1K042007Zoll E Series DefibrillatorZoll Medical Corp20053
0 (this device)K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters2011—
+1K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters2011—
+1K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20122
+2K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters2012—
+2K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters2014—
+2K121367Zoll Propaq XMZOLL Medical Corporation20121

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199620
199940
200010
200110
200211
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201230
201450
201520
201810
202010
202110
202410
FIG. 1 — Lineage of K110168, 1997–2024Source: 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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? (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
*K042007Zoll E Series Defibrillator
Summary page 1
…11 (21 CFR Part 870.5310) Cardiopulmonary Resuscitation Aid: Class 111 (21 CFR 870.5200) Description: The ZOLL E Series, reviewed and cleared under 510(k) K042007 and K062177, is a portable device designed to be used by trained emergency care personnel in both the hospital and pre-hospital a…
Zoll Medical Corp20053
*K062177Zoll E Series with Real CPR Help
Summary page 1
…art 870.5310) Cardiopulmonary Resuscitation Aid: Class 111 (21 CFR 870.5200) Description: The ZOLL E Series, reviewed and cleared under 510(k) K042007 and K062177, is a portable device designed to be used by trained emergency care personnel in both the hospital and pre-hospital arenas. The Z…
ZOLL Medical Corporation2006—

Also cleared against K042007: 8 other devices →

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110
K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20128

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

  • The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
  • 5 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K111594 (Zoll Medical Corporation, World Wide Headquarters, 2011) has gone furthest, with 10 descendants of its own.
  • 8 other devices also cite its predicate K042007.

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. 2011, 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—

What is it indicated for?

Defibrillator Function The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Do not…

Read the full statement (699 words)

Defibrillator Function

The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation.

The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team.

Do not use the unit's AED function on patients under 8 years of age.

Intended Use - Manual Operation

Use of the E Series products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:

* Unconsciousness

* Absence of breathing, and

* Absence of pulse.

This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

In Manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate.

The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).

Intended Use - Semiautomatic Operation (AED)

The E Series AED unit is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.

They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.

Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.

Intended Use - CPR Monitoring

The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients.

The CPR monitoring function is not intended for use on patients under 8 years of age.

Intended Use - Pacemaker

This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endlocardial stimulation.

Note: This device must not be connected to internal pacemaker electrodes.

The purposes of pacing include:

Resuscitation from standstill or bradycardia of any etiology

Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug induced standstill (due to procainamide, quinidine, digitalis, b-blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endlocardial or other temporary electrodes.

As a standby when standstill or bradycardia might be expected

Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.

Suppression of tachycardia

Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.

Pediatric Pacing

Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K110168: Zoll E Series with 2010 Aha Guidlines Software Update.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110168

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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