510(k) · Cleared
Recalled · 2011Zoll E Series Defibrillator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Medical Corp · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Apr 7, 2005 as substantially equivalent to K990762 (Zoll Medical Corp, 1999) and 5 other predicates after a 255-day review. Its family tree reaches back 6 generations to 1997. 1 of the 82 devices in its family, counting itself, has a Class I recall. 64 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 7, 2005
- Review
- 255 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 3
- Predicates
- 6
Its longest line of descent runs back 6 generations to K962603 (1997). 17 ancestors in all, the oldest K945071 (1995). 64 later devices descend from it, 9 citing it directly. 1 of the 82 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 1 generation backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- This deviceK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005
- Descendant · cites it directly · 27 of its ownK090989 Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009
- Descendant · 2 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- Descendant · cites it directly · 21 of its ownK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled
- Descendant · 3 generations on · 16 of its ownK171121 Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017
- Descendant · cites it directly · 15 of its ownK110168 Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes2 generations back · 2002
Most influential descendants
Showing 5 of 64 · See all- K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009 · cites it directly27descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 2 generations on24descendants
- K060559Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · cites it directly21descendants
- K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017 · 3 generations on16descendants
- K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −1 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| 0 (this device) | K042007 | Zoll E Series Defibrillator | Zoll Medical Corp | 2005 | — |
| +1 | K090989 | Zoll R Series with Nibp and ETCO2 Options, Zoll R Series | Zoll Medical Corp | 2009 | — |
| +2 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| +1 | K060559 | Zoll R Series Defibrillator | ZOLL Medical Corporation | 2006 | 1 |
| +3 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | — |
| +1 | K110168 | Zoll E Series with 2010 Aha Guidlines Software Update | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 1 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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
What was it cleared against? (6)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990762 | Zoll M Series with Rectilinear BI-Phasic Option (M Series BI-Phasic)Summary page 2…e: koL/J)"07 The features and functions of the ZOLL E SERIES are substantially equivalent to those of the ZOLL M SERIES Biphasic: 510(k) No. k990762, cleared 9/03/1999, the M SERIES SPO2 Option 510(k) No. K982992, cleared 3/11/1999, the M SERIES End Tidal CO2 Opti… | 1999 |
| * | K982992 | Zoll M Series SPO2 OptionSummary page 2…LL E SERIES are substantially equivalent to those of the ZOLL M SERIES Biphasic: 510(k) No. k990762, cleared 9/03/1999, the M SERIES SPO2 Option 510(k) No. K982992, cleared 3/11/1999, the M SERIES End Tidal CO2 Option: 510(k) No. K993036 cleared 2/28/2000, the M SERIES 12SL Anal… | 1999 |
| * | K993036 | Zoll M Series ETCO2 OptionSummary page 2…hasic: 510(k) No. k990762, cleared 9/03/1999, the M SERIES SPO2 Option 510(k) No. K982992, cleared 3/11/1999, the M SERIES End Tidal CO2 Option: 510(k) No. K993036 cleared 2/28/2000, the M SERIES 12SL Analysis Option 510(k) No. K991556 cleared 10/21/1999, the M SERIES Non-Invasi… | 2000 |
| * | K991556 | Zoll M Series 12SL Analysis OptionSummary page 2…10(k) No. K982992, cleared 3/11/1999, the M SERIES End Tidal CO2 Option: 510(k) No. K993036 cleared 2/28/2000, the M SERIES 12SL Analysis Option 510(k) No. K991556 cleared 10/21/1999, the M SERIES Non-Invasive Blood Pressure measurement Option: 510(k) No. K032363, cleared 10/31… | 1999 |
| * | K032363 | Zoll M Series Nibp OptionSummary page 2…0, the M SERIES 12SL Analysis Option 510(k) No. K991556 cleared 10/21/1999, the M SERIES Non-Invasive Blood Pressure measurement Option: 510(k) No. K032363, cleared 10/31/2003, and the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004. Intended Use: Defibrillation… | 2003 |
| * | K033474 | Zoll Aed PlusSummary page 2…cleared 10/21/1999, the M SERIES Non-Invasive Blood Pressure measurement Option: 510(k) No. K032363, cleared 10/31/2003, and the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004. Intended Use: Defibrillation Use of the E Series products in the manual mode for defibri… | 2004 |
What descends from it? (64)
See all 649 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090989 | Zoll R Series with Nibp and ETCO2 Options, Zoll R Series | 2009 | 27 |
| K060559 | Zoll R Series Defibrillator | 2006 | 21 |
| K110168 | Zoll E Series with 2010 Aha Guidlines Software Update | 2011 | 15 |
| K090801 | Electronic House Call | 2009 | 3 |
| K080903 | Zoll E Series with Intibation Assist Option | 2008 | 3 |
| K092598 | Zoll E Series with Spco/Spmet Option | 2009 | 2 |
| K091265 | Zoll E Series with Cprreadycharge | 2009 | 0 |
| K081081 | Zoll E Series with Bluetooth Dial UP Networking | 2009 | 0 |
| K080232 | Zoll E Series 12SL, Analysis Option | 2008 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2011 | Not classified | Z-2294-2011 | Software design | Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy |
| Mar 24, 2010 | Not classified | Z-1547-2010 | Software design | Device issued Shock Advised message but failed to auto-charge the defibrillator. |
| Jan 15, 2008 | Not classified | Z-1167-2008 | Software design | Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct. |
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 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K090989 (Zoll Medical Corp, 2009) has gone furthest, with 27 descendants of its own.
- 1 other device also cites its predicate K990762.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 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. Intended Use - Manual Operation Use of the E Series products in the manual mode for defibrillation is indicated on…
Read the full statement (687 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.
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:
Unconsciousness
Absence of breathing
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.
Intended Use - Semiautomatic Operation (AED)
The E Series products are 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.
The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team.
Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
Unconsciousness
Absence of breathing
Absence of pulse.
External Pacemaker (Pacer Version Only)
Intended Use - Pacemaker
This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial 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, 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 endocardial 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.
Monitor
Intended-Use Multi-parameter Monitoring
This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP).
ECG monitoring is indicated by connecting the patient to the unit via the 3 or 5 lead patient cable, MFE Pads, or through the paddles.
SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.
EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients.
12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction.
NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042007: Zoll E Series Defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042007
Report an extraction error
Are you the manufacturer?
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