510(k) · Cleared
ClearedZoll E Series Als
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZOLL Medical Corporation · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Nov 6, 2014 as substantially equivalent to K111594 (Zoll Medical Corporation, World Wide Headquarters, 2011) and 1 other predicate after a 252-day review. Its family tree reaches back 9 generations to 1997. 1 of the 24 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Nov 6, 2014
- Review
- 252 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K962603 (1997). 22 ancestors in all, the oldest K945071 (1995). 1 later device descends from it, 1 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
- 2 generations backK110168 Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011
- 1 generation backK111594 Zoll E SeriesZoll Medical Corporation, World Wide Headquarters · 2011
- This deviceK140502 Zoll E Series AlsZOLL Medical Corporation · 2014
- Descendant · cites it directly · 0 of its ownK200849 Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020 · Recalled
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 3 generations backK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
- 2 generations backK110168 Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011
- 1 generation backK111594 Zoll E SeriesZoll Medical Corporation, World Wide Headquarters · 2011
- This deviceK140502 Zoll E Series AlsZOLL Medical Corporation · 2014
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes4 generations back · 2002
Most influential descendants
Showing 1 of 1 · See all- K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −3 | K042007 | Zoll E Series Defibrillator | Zoll Medical Corp | 2005 | 3 |
| −2 | K110168 | Zoll E Series with 2010 Aha Guidlines Software Update | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
| −1 | K111594 | Zoll E Series | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
| 0 (this device) | K140502 | Zoll E Series Als | ZOLL Medical Corporation | 2014 | — |
| +1 | K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020 | 4 |
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 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
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.
Top candidate predicates for a new LDD device
- #1 K200849 Tempus LS - Manualscore 1.3 · 13 generations · no Class I recall
- #2 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111594 | Zoll E SeriesSummary page 6…Carbon Dioxide Gas Analyzer (CCK) Oximeter (DQA) Predicate Devices ZOLL E Series (K111594 and K092598)… | 2011 |
| * | K092598 | Zoll E Series with Spco/Spmet OptionSummary page 6…Analyzer (CCK) Oximeter (DQA) Predicate Devices ZOLL E Series (K111594 and K092598) 5-1… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200849 | Tempus LS - Manual | 2020 | 0 |
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 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200849 (Remote Diagnostic Technologies, Ltd. A Philips Company, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K111594.
How does its category compare?
All LDD devicesLDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LDD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LDD
124in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDD
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDD
74in 2025
MAUDE reports naming product code LDD, 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 | 0 | — | 0 | 550 |
| 2008 | 2 | — | 11 | 1,214 |
| 2009 | 0 | — | 1 | 1,057 |
| 2010 | 2 | — | 0 | 635 |
| 2011 | 4 | 124 | 1 | 386 |
| 2012 | 0 | — | 0 | 398 |
| 2013 | 0 | — | 0 | 602 |
| 2014 | 1 | — | 2 (2) | 481 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 0 | — | 0 | 58 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 0 | — | 0 | 28 |
| 2019 | 1 | — | 0 | 34 |
| 2020 | 1 | — | 1 | 19 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 264 |
| 2024 | 0 | — | 2 | 160 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The E Series ALS 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 ALS products must be prescribed for use by a physician or medical advisor of an emergency response team. Use of the E Series…
Read the full statement (759 words)
The E Series ALS 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 ALS products must be prescribed for use by a physician or medical advisor of an emergency response team.
Use of the E Series ALS 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 ALS 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 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.
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.
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.
This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 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.
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.
SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.
SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood 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 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/K140502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140502: Zoll E Series Als.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140502
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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