510(k) Report

510(k) · Cleared

Cleared

Zoll E Series with See-Thru CPR

K070455510(k) SpecialCleared Apr 26, 200769-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 Apr 26, 2007 after a 69-day review. The FDA summary names no predicate by number. 9 later devices descend from it.

Decided
Apr 26, 2007
Review
69 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2012: 2 descendants cleared2014: 4 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared20052010201520202025
  1. This deviceK070455 Zoll E Series with See-Thru CPRZoll Medical Corporation, World Wide Headquarters · 2007
  2. Descendant · cites it directly · 8 of its ownK112432 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
  4. Descendant · 2 generations on · 3 of its ownK121367 Zoll Propaq XMZOLL Medical Corporation · 2012 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK180482 ZOLL Propaq MZOLL Medical Corporation · 2018
  6. Descendant · 3 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2012: 22014: 42018: 12021: 12024: 1
2012high 4 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 9 · See all
  • K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · cites it directly8descendants
  • K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 2 generations on4descendants
  • K121367Zoll Propaq XMZOLL Medical Corporation · 2012 · 2 generations on3descendants
  • K180482ZOLL Propaq MZOLL Medical Corporation · 2018 · 3 generations on2descendants
  • K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070455Zoll E Series with See-Thru CPRZoll Medical Corporation, World Wide Headquarters2007—
+1K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20122
+2K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters2014—
+2K121367Zoll Propaq XMZOLL Medical Corporation20121
+3K180482ZOLL Propaq MZOLL Medical Corporation2018—
+3K141774Zoll X SeriesZOLL Medical Corporation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201440
201810
202110
202410
FIG. 1 — Lineage of K070455, 2007–2024Source: 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), 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20128

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, K112432 (Zoll Medical Corporation, World Wide Headquarters, 2012) has gone furthest, with 8 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. 2007, 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?

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…

Read the full statement (733 words)

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.

Pacing can be performed on pediatric patients weighing 331bs / 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 (SPO 2), End Tidal GO2, 12-Lead EGG, 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, MVFE Pads, or through the paddles.

SP02 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 EGG 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.

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.

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.

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.

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.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K070455: Zoll E Series with See-Thru CPR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070455

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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