510(k) · Cleared
ClearedZoll E Series with Real CPR Help
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZOLL Medical Corporation · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Dec 13, 2006 after a 135-day review. The FDA summary names no predicate by number. 16 later devices descend from it.
- Decided
- Dec 13, 2006
- Review
- 135 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK062177 Zoll E Series with Real CPR HelpZOLL Medical Corporation · 2006
- Descendant · cites it directly · 15 of its ownK110168 Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011
- Descendant · 2 generations on · 10 of its ownK111594 Zoll E SeriesZoll Medical Corporation, World Wide Headquarters · 2011
- Descendant · 2 generations on · 8 of its ownK112432 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · Recalled
- Descendant · 3 generations on · 6 of its ownK120907 Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012
- Descendant · 3 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011 · cites it directly15descendants
- K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters · 2011 · 2 generations on10descendants
- K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 2 generations on8descendants
- K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 3 generations on6descendants
- K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062177 | Zoll E Series with Real CPR Help | ZOLL Medical Corporation | 2006 | — |
| +1 | K110168 | Zoll E Series with 2010 Aha Guidlines Software Update | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
| +2 | K111594 | Zoll E Series | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
| +2 | K112432 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | 2 |
| +3 | K120907 | Zoll R Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | — |
| +3 | K133269 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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.
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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110168 | Zoll E Series with 2010 Aha Guidlines Software Update | 2011 | 15 |
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, K110168 (Zoll Medical Corporation, World Wide Headquarters, 2011) has gone furthest, with 15 descendants of its own.
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. The E Series products must be prescribed for use by a physician or medical advisor of an emergecy response team.…
Read the full statement (841 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 emergecy response team.
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. Aqualified physician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricualr 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 compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients.
The CPR monitoring function is not intended for use on patients under 8 years of age.
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, 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 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 (SpO 2 ), End Tidal CO 2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP),
ECG monitoring is performed by connecting the patient to the unit via the 3 or 5 lead patient cable, MFE Pads, or through the paddles.
SpO 2 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.
EtCO 2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO 2) 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 or other cardiac arrhythmias.
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/K062177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062177: Zoll E Series with Real CPR Help.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062177
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